The US Food and Drug Administration (FDA) has approved a new colorectal screening test called Cologuard. The Cologuard test (or assay) can check stool samples for DNA alterations/abnormalities that are known to happen with colorectal cancer and polyps.
This is an exciting new tool that could increase the number of patients who get screened for colon cancer prevention. Anything that boosts awareness of early colorectal cancer detection is a benefit. Colorectal cancer screening is effective at reducing illness and death related to colon cancer. The Centers for Disease Control and Prevention estimates that if everyone age 50 or older had regular screening tests as recommended, at least 60 percent of colorectal cancer deaths could be avoided.
What this Colorectal Screening Test Is Like
The test does not require patients to follow a special diet or use a “prep.” Users collect a stool sample for testing in their home bathrooms and send the sample to the Cologuard manufacturer in a prepaid package. Patients can then discuss the results with their doctors.
One limitation of this colorectal screening test: If patients have an abnormal test result, they will still need to undergo a colonoscopy. I suspect that most patients who will use this assay may be trying to avoid a colonoscopy.
Furthermore, it remains to be seen is how well patients will accept this new product. There has been low patient acceptance and use with previous stool-based colorectal screening tests.
The FDA pointed out that its approval of the new assay does not change current guidelines for colorectal cancer screening. Among other guidelines, the United States Preventive Services Task Force recommends anyone at average risk for colon cancer who is between 50 and 75 years old to undergo screening using fecal occult blood testing, sigmoidoscopy or colonoscopy.
On the same day as the FDA approval, the Centers for Medicare and Medicaid Services (CMS) issued a proposed national coverage determination for the product. Manufactured by Exact Sciences in Madison, WI, Cologuard is the first product to undergo a “parallel review” via the FDA and the CMS to expedite the process of getting Medicare coverage after FDA approval.