New At-Home Colon Cancer Test: FAQ
Cologuard was also better than the FIT at finding pre-cancerous growths. It detected 42%, while FIT found 24%.
The downside, though, is that the new test was not as good at finding “true negatives.” (A negative test result means the disease being tested for was not found.) Cologuard correctly identified a negative result in 87% of patients, the FDA says, but FIT did so in 95%.
Will the new test replace other tests or supplement them?
It won't replace other tests, but will be another option, experts say. If the test result is positive from Cologuard, a colonoscopy is then needed.
The test is meant for those at average risk of colon cancer, the company says. Even so, there may be a role for it in someone with a family history, Galier says. For instance, a doctor might order it for high-risk people in between regular colonoscopies.
Recent guidelines from the U.S. Preventive Services Task Force, an independent panel of experts, recommend that adults ages 50 to 75 at average risk for colon cancer be screened using fecal occult blood testing, sigmoidoscopy (a more limited exam than colonoscopy), or colonoscopy.
The recommended intervals for each option are annually for fecal occult blood tests, every 5 years for sigmoidoscopy, and every 10 years for colonoscopy, the task force says.
The other question to be answered, Galier says, is how often the Cologuard test is needed. The guidelines have not yet been set up, says Jennifer Netzband, a spokeswoman for the test's maker, Exact Sciences.
Dr. Lin of City of Hope welcomes the new test, saying some patients who avoid colonoscopies may agree to it. "Ultimately the best colon cancer screening test is the one the patient is using," he says.
Cologuard is pricey, compared to the FIT, which is about $30. Will insurance cover it?
That's yet to be determined, Netzband says.
The Centers for Medicare and Medicaid Services (CMS) propose that the test be reimbursed every 3 years for those ages 50 to 85, without symptoms of colon cancer and considered average risk. The decision on that is expected by October or November.
Insurance companies often follow CMS decisions about coverage.