FDA Expands ColoGuard Approval: What This Means for Individuals 45 and Older

The Food and Drug Administration (FDA) expanded its approval of Cologuard, an at-home non-invasive colorectal cancer screening test, to include use among average-risk individuals aged 45 and older.

The agency’s expanded approval comes at a time when the country has seen a 51% increase in colorectal cancer among people younger than 50 since 1994, according to Exact Sciences — the manufacturer of the stool test. Moreover, the corporation noted in a release, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50 between 2004 and 2005, of which more than half were diagnosed at an advanced stage.

“They say that the only bad test is the test that doesn’t get done. So, any tests that we can get the general public to do for basic screening is the best test,” Teri, a colorectal cancer survivor who was diagnosed with the disease at 48, said in an interview with CURE. “To have an option such as Cologuard, that is non-invasive and can be done at home, that means less barriers or excuses to not have screening done. I really can't imagine how many lives we're going to be able to save in the future by having this available.”

Screening Guidelines

In tandem with rising numbers of younger individuals being diagnosed with colorectal cancer, the American Cancer Society issued updated guidelines in Many 2018 to recommend that screening begin at age 45

“The drop in the screening age by the American Cancer Society was a pretty monumental moment for the colorectal cancer community. We were very concerned about seeing the rise in incidence rates under the age of 50. So, seeing the leadership there was an important first step,” Davis said, adding that this approval aligns with the society’s initiatives.

“We're all very appreciative that the FDA followed suit and provided us another screening option as we look to screen a new population of eligible patients between the ages of 45 and 50,” she said. “From our perspective, we need as many tools as we can because we need to screen more people and we need to reach this high-risk population because we are seeing a rise in incidence rates under 50.”

Speaking from Experience

After not feeling 100% during her Iron Man triathlon training, and also experiencing blood in her stool, Teri attributed her issues to riding her bike for long distances or the anti-inflammatory she was taking. However, after her race was complete, what she had been experiencing didn’t go away.

She confided in a family friend, who is a gastroenterologist and, luckily enough, urged her to undergo a colonoscopy as soon as possible. At the age of 48, Teri was diagnosed with metastatic colorectal cancer.

“I woke up from (the colonoscopy) and (our family friend) said there was a huge tumor and that he knew it was cancerous,” Teri said. “In the snap of a finger, my life had changed forever.”

Following her experience, she urges individuals to advocate for themselves to be properly screened for colorectal cancer — something this approval can help do. “Realize it's about awareness, it's about saving lives. It's about a new option out there that easy to do,” Teri said.

Cutting the Excuses

In addition to those who are at a higher risk, the expanded approval of Cologuard can help the general population. “The FDA approving Cologuard provides us some continuity with the guidelines and provides an additional tool for patients that may be hesitant to look for an invasive screening test, or maybe colonoscopy isn't an option for them,” Anjee Davis, president of Fight Colorectal Cancer, said in an interview with CURE.

This is overly important given the fact that delayed screening often results in a later-stage diagnosis. With that, only about one in 10 people with stage 4 colorectal cancer survive beyond five years.

“Anything we can provide the general public to make it easier for them, to make the choice to be screened, the better the outcomes — the key being that colorectal cancer is a preventable cancer,” Davis added. “These innovations, these new non-invasive tests and options are great options for the general public when they're trying to make a choice of, ‘Should I be screened for colorectal cancer? Do I have time to be screened for colorectal cancer?’ And we just have to make sure they say ‘I have to do this.’”

Raising Awareness

Lastly, the hope with this approval from the FDA is that it continues to raise awareness around the fact that colorectal cancer is occurring at higher rates among younger individuals, Davis said.

“It's another opportunity for us to have a conversation around screening and another conversation around the screening age,” she said. For 50 years, we've been saying the age was 60. But now we have our charge to educate the general public, physicians, health care providers and family members who have been impacted by colorectal cancer…This approval is an opportunity for us to engage our advocacy community to have conversations with people and remind them that the new screening age is 45, and the more we can talk about it, the better.”