The Food and Drug Administration has approved another noninvasive alternative to colonoscopy for screening for colorectal cancer, this one a stool-based test that detects the presence of red blood cells and DNA mutations.
And the same day as the FDA approval, the Centers for Medicare & Medicaid Services said that it was starting to review the technology with an eye toward approving it for Medicare beneficiaries.
The Cologuard, made by Exact Sciences of Madison, Wisc., is prescribed by a physician. It is mailed to the patient, who collects a stool sample and sends it to Exact Sciences for analysis. The $599 diagnostic detects hemoglobin and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Results – which are simply positive or negative for precancerous polyps or cancer – are reported by the prescribing physician. Patients with positive results are advised to undergo a diagnostic colonoscopy.
The test is not a substitute for colonoscopy; it is an alternative to fecal occult testing, and in trials, the Cologuard "detected more cancers than a commonly used fecal occult test," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement.
The FDA pointed out that approval does not change the currently recommended colorectal cancer screening protocols. Stool DNA testing is not recommended by the United States Preventive Services Task Force, for instance. Among other guidelines, the USPSTF recommends adults aged 50-75 years, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.
"This approval offers patients and physicians another option to screen for colorectal cancer," said Dr. Gutierrez.
Dr. David A. Ahlquist, a Mayo Clinic gastroenterologist who was a coinventor of the test, said in a statement issued by Exact Sciences that the clinical studies had "proven that this noninvasive test is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer."
According to the FDA, in the 10,000-patient study, Cologuard accurately detected cancers and advanced adenomas more often than did the fecal occult test. Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas; fecal occult screening detected 74% of cancers and 24% of advanced adenomas. Cologuard, however, was less accurate than fecal occult was at correctly identifying subjects negative for colorectal cancer or advanced adenomas.
For the first time ever, the CMS also proposed coverage of a product on the same day as it was approved, said Dr. Patrick Conway, chief medical officer and deputy administrator for innovation and quality at CMS, in a statement. The CMS analysis "will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer," said Dr. Conway.
The agency is proposing to cover Cologuard once every 3 years for Medicare beneficiaries who are aged 50-85 years, asymptomatic (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), and are at average risk of developing colorectal cancer.
The CMS is accepting comments until Sept. 11, 2014. It did not give a timeline for when it would make a final coverage decision.
Dr. Ahlquist and the Mayo Clinic will share equity and royalties from Exact Sciences.
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