For people who prefer to take an at-home test for colorectal cancer rather than undergo a colonoscopy, Cologuard has become a popular choice. An upgraded version of this screening tool, for adults 45 and older with an average risk for colorectal cancer, will be available this spring.
“This is a meaningful improvement in colorectal cancer screening,” says Sean Langenfeld, MD, a professor and colorectal surgeon at Nebraska Medicine in Omaha. Dr. Langenfeld isn’t involved with Exact Sciences, the manufacturer of the test.
New Test Identifies 95 Colorectal Cancer Cases Out of 100
The original Cologuard was approved by the U.S. Food and Drug Administration (FDA) in 2014. The test provides a kit that allows a person to collect a stool sample (poop) from the comfort of home using a specially designed paper that fits over the toilet The user then mails the sample to the Exact Sciences laboratory in a provided container.
The lab analyzes the stool for blood as well as genetic abnormalities associated with colorectal cancer.
That means that out of every 100 people who have colorectal cancer, Cologuard Plus will correctly identify 95 of them and miss 5 cases.
The updated Cologuard Plus test also has reported a higher specificity of 94 percent. That means it is also very good at identifying who doesn’t have colorectal cancer. The original Cologuard had an 87 percent specificity. Higher specificity correlates to fewer unnecessary follow-up colonoscopies from false positive results.
Finally, the new test allows for more time to send the sample. People using the original have four days, while those using Cologuard Plus have six days because of different preservatives.
These improvements to the old Cologuard are meaningful, says Langenfeld.
“By decreasing false positives, it reduces the number of patients who have to undergo a follow-up invasive procedure. In a similar vein, it reduces the number of patients who had a positive Cologuard, then underwent a colonoscopy where nothing was found and are left feeling worried that something may have been missed,” he says.
And expanding the allowed time for specimen return will help more people successfully mail in their sample, and allow for more stable and reliable results, says Langenfeld.
How Cologuard Plus Stacks Up to Another At-Home Option
Cologuard’s approval was based on a head-to-head trial that compared Cologuard Plus with a fecal immunochemical test (FIT), which screens for early signs of colon cancer by detecting blood (that can’t be seen by just looking at it) in the stool.
The study included about 20,000 people aged 40 and over. Around 40 percent of participants identified as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander.
Colonoscopy Is Still the Gold Standard for Colorectal Cancer Screening
“For those of us that remove colorectal cancer for a living, we are always going to recommend colonoscopy for our patients and our families, as it can not only detect cancers, but also precancerous polyps, and it has the ability to simultaneously remove lesions,” says Langenfeld.
But the reality is that there are more patients needing screening than there are openings on an endoscopist’s schedule (the person who performs colonoscopies), he says.
“Additionally, plenty of people go unscreened due to the stigma, cost, and concern for complications with an invasive procedure,” says Langenfeld.
A colonoscopy requires a full bowel prep, sedation, and a day off from work. “There are many people who are either unable or unwilling to undergo colonoscopy,” he says.
Offering noninvasive screening options can expand testing access and capture people who would otherwise go without any screening at all, says Langenfeld.
At the end of the day, the best screening test is the one that the person is willing to undergo, he says.
“The improvement in the quality and ease of use for noninvasive tests is a step in the right direction,” says Langenfeld.
Will Insurance Cover Cologuard Plus?
When it becomes available this spring, Cologuard Plus will be covered for all Medicare Part B patients with no out-of-pocket cost, says Paul Limburg, MD, chief medical officer of screening at Exact Sciences.
Exact Sciences is currently negotiating rates with individual insurers to pay for Cologuard Plus. Because colorectal cancer screening is covered as a preventive service, patients rarely receive a bill, he says.
During an initial transition period, people whose insurance does not yet offer coverage can still be screened with the original Cologuard test. “That way, we can continue to provide effective colorectal cancer screening without any disruptions in coverage,” says Dr. Limburg.
Colorectal Cancer Screening Saves Lives
Colorectal cancer is the second-leading cause of cancer death in the United States when men and women are combined, but it’s also one of the most preventable cancers when detected early.
The FDA has approved Cologuard and Cologuard Plus for people with average risk.
- Personal history of colorectal cancer or certain types of polyps
- Family history of colorectal cancer
- Personal history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease)
- Confirmed or suspected hereditary colorectal cancer syndrome
- Personal history of getting radiation to the abdomen or pelvic area to treat a prior cancer