How out-of-the-box thinking convinced Americans to try Cologuard’s colorectal cancer screening test

What do an animated cardboard box, a famously relatable celebrity journalist and the PGA Tour have in common? They’re all part of Exact Sciences’ marketing strategy for its colorectal screening test Cologuard.

The well-entrenched colonoscopy test is the “gold standard” of colorectal cancer screening, and executives at Exact Sciences knew from the beginning that they would have to break the marketing mold to gain traction in the market. Cologuard is not as invasive as a colonoscopy, but its very different modality — collecting and sending a stool sample through the mail — called for a new way of thinking.

Despite some early naysayers and a plethora of “poop-in-a-box” wisecracks, the company’s strategy seems to be working. An estimated four million people will take a Cologuard test this year — up from about three million last year and a big leap from less than a decade ago when it was approved by the FDA. However, those figures are still a fraction of the 60 million people who are at average risk of colorectal cancer but are not caught up on their colorectal screenings. And that’s where Exact has set its sights.

The colorectal screening market is undergoing big changes. Two years ago, an influential group of medical experts followed the American Cancer Society and others recommending that people start getting screened at age 45 rather than 50. That means an additional 15 to 20 million people who can now be screened. Plus, there’s a backlog of prescreens skipped during the pandemic, a declining number of gastroenterologists and already long wait times at hospitals and outpatient centers. And so Exact Sciences is leaning into the reality that all the screenings can’t be done through colonoscopies alone.

Its not-so-secret secret? A multi-faceted, blanket marketing and sales approach that includes the talking white-and-blue box Exact calls “Little CG,” a partnership with the popular journalist and colon cancer screening advocate Katie Couric and the Cologuard Classic on the PGA Tour. It also includes an almost 1,000-person sales force calling on healthcare providers, office staff, payers and specialists at advocacy groups, said chief commercial officer Everett Cunningham.

Everett Cunningham

For Cunningham, the key to the strategy isn’t just the novelty and appeal of “Little CG,” Couric’s wide and instant recognition or even the day-to-day outreach work by its large field force. It’s consistency.

“The consistency of messaging, the consistency of sales calls, the consistency of understanding our customers — it just gets better every single month,” he said. “Introducing a new modality to the market takes time, especially when that modality is different. It takes years until you get momentum.”

Now, he says, Exact Sciences has that momentum. The year-over-year consistent strategy, which includes embracing pop culture parodies with good humor, as it did with a “Saturday Night Live” skit earlier this year, has not only normalized the “poop-in-a-box” test but has also transformed the $15 billion colorectal cancer screening market.

Michael Sapienza

Michael Sapienza, CEO of the Colorectal Cancer Alliance, said Exact has “100%” changed the colorectal cancer screening market in several ways. Its industry-first, direct-to-consumer advertising and its “unheard of” navigation services that guide people through the process with support and reminders clock in at a significantly above-average adherence rate of around 70%.

“Tests like Cologuard can play a huge role in screening, not just for people who are busy, but for those who are underserved and at average risk who don’t want to get a colonoscopy or who don’t need to,” Sapienza said.

Still, there are a lot of Cologuard jokes. Along with the SNL skit, there are parodies, memes and even Halloween costumes. Yet, it all adds up to more media attention that drives awareness of the brand and the broader acceptance of Cologuard’s alternative method of colorectal cancer screening.

“No one was happier to see Little CG on ‘Saturday Night Live’ than we were,” said Daniel Mailliard, executive VP and group creative director at FCB Health, Exact’s ad agency. Both FCB and Exact sent out social messages about the skit, and FCB went a step further, sending out Little CG audition tapes to media outlets to let them know the box was ready for his next acting gig.

“We embrace those conversations. For us, it is a bigger conversation than ‘yes, you do have to poop in a box,’ but the end result of that means bringing you peace of mind or early detection outweighs any discomfort,” he said. “The more people are talking about it, the more we want to embrace it. I think it lessens the stigma.”

By now, most people have seen the TV commercials starring the white-and-blue animated box spokescharacter that lays out facts and no-nonsense explanations about how the test works. More recently, though, Exact and FCB Health began a “My Way” campaign. Little CG takes a smaller role in the new work, appearing in the background as people older than 45 sing remixed lyrics about using the Cologuard test set to the Frank Sinatra classic tune.

“I’m over 45. I realize I’m no spring chicken. I know what’s right for me. I got a plan to which I’m sticking. My doc wrote me the script. Box came by mail. Showed up on Friday. I screened with Cologuard and did it my way,” a group of actors in the TV spot sing.

The campaign reinforces a recommendation made by the US Preventive Services Task Force in 2021 that screening should begin at age 45 instead of age 50 for people at average risk of colorectal cancer.

The American Cancer Society, the Colorectal Cancer Alliance and many insurers adopted the 45-year-old guideline two years ago, but the decision for the task force, which makes preventative service decisions followed by Medicare and Medicaid under the Affordable Care Act, became final in January. That means colorectal screenings, via colonoscopy or Cologuard, for people who are at least 45 are covered without copays or coinsurance. Medicare has long covered the Cologuard test, as does Medicaid in 41 states.

Cologuard must be prescribed by a physician, but it is not considered a replacement for a colonoscopy. Anyone who receives a positive test, as well as anyone who has risk factors like family history for colon cancer or suffering from inflammatory bowel diseases, should get a colonoscopy.

The marketing campaign’s success has also been reinforced by Cologuard’s sales figures. Exact Sciences recently reported that screening sales jumped 37% to $906 million in the first six months of this year, and in August, the company increased its sales guidance by $45 million for the year. Exact took in $1.43 billion in screening test sales in 2022, and it now estimates $1.82 billion to $1.84 billion for 2023.

And there’s likely more to come. Exact recently shared Phase III results in June for its so-called Cologuard next-generation product, saying it met all endpoints and improved topline measures, including a 30% reduction in false positives. Cunningham declined to talk about any marketing plans for the newer test, saying he and his team are focused on  the current test.

Kevin Conroy

Exact CEO Kevin Conroy told investors on the second-quarter earnings call this month that the company is planning an FDA submission by the end of this year for the next-generation product, followed by an expected nine-to-12-month wait for a decision.

For Cunningham, advocating for the adoption of the Cologuard test is his job, but it’s also a personal mission. When he took the job with Exact Sciences two years ago, he had entered his fifties but had not had a colorectal cancer screening. Neither had his wife, who is a physician.

“I told her then ‘We have to get screened. I can’t sit in front of thousands of people and talk about the importance of screening and we’re not screened,’” he said.

She agreed, and they both took Cologuard tests. His was negative, but hers was positive. Still, they weren’t worried — she was healthy, fit and felt fine. She went for a follow-up colonoscopy as recommended, and doctors discovered a six-centimeter mass, the size of a grapefruit, as he described it, in her colon. She ended up having a colectomy to remove one third of her colon and the pre-cancerous mass.

“So many people are walking around saying ‘I’m healthy, I’m asymptomatic. Is there really a need for me to do this non-invasive test or a colonoscopy?’ ” Cunningham said. “That’s my mission now. I’m going to make sure until the day I retire, we’re going to go out and be passionate about getting people screened.”

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