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Unbranded – Lifestyle
Jeff Smith was stunned when he received a colon cancer test kit in the mail.
The 68-year-old Minnesota man did not request the Cologuard test, and his doctor did not mention it. And why on earth do we need such a test? Smith has lived without a colon for most of his life. As a child, he had ulcerative colitis, an inflammatory bowel disease. Doctors removed his colon.
Some doctors are concerned about the idea of mailing tests to patients without consulting their doctor first, because in Smith’s experience, it involved an additional and uncomfortable test after the kit was completed. Early detection of colon cancer is important. According to the American Cancer Society, colon cancer is the second leading cause of cancer death in the United States, with nearly 53,000 people expected to die from colon cancer in 2025.
However, this disease is highly treatable if detected early. Screening is recommended for adults ages 45 to 75 who are at average risk. However, nearly one in three eligible adults do not have up-to-date information about colon cancer screening.
Consumers have more testing options beyond the once-a-decade colonoscopy. Tests are available that can detect signs of disease in a person’s stool, and the Food and Drug Administration approved a blood test in 2024. Exact Sciences, the company that sells the Cologuard test, worked with health insurance companies and health systems to send kits to the homes of people who had never been tested for colon cancer or who were overdue for a test.
Some physicians not affiliated with Exact Sciences have questioned the at-home screening program. They worry that in some cases doctors will be excluded from the decision-making process, which could lead to inappropriate testing — just as Smith faced, they say.
One of the Smith doctors, Naresh Gunaratnam, is a gastroenterologist and president of the Digestive Health Physicians Association, which represents approximately 3,000 physicians specializing in gastrointestinal care. He said he was concerned that these mail-in tests could be inappropriately prescribed and cause anxiety and worry for patients.
“You’re destroying the doctor-patient relationship,” Gunaratnam said.
How does the Cologuard home inspection program work?
Paul Limberg, chief medical officer of screening at Exact Sciences, said the company is partnering with several major insurance companies and health systems to ship Cologuard kits to the homes of people scheduled for screening.
Health plans send a list of eligible patients to Exact Sciences, and Exact Sciences performs its own checks to ensure someone is scheduled for screening. Must not have been screened with Cologuard within the past 3 years. High-risk patients with genetic conditions that increase the risk of colon cancer may require more frequent testing than those at average risk.
Limburg cited research published by the Centers for Disease Control and Prevention about another colon cancer test that was mailed to the homes of people scheduled for screening. The CDC study looked at local health centers that mail fecal immunochemical tests (FIT tests) to patients.
Cologuard and FIT tests are cheaper and easier to complete than a colonoscopy. However, if the test result is positive, a follow-up colonoscopy may be required.
Linberg said the program is designed to reach people who have not been able to get tested due to lack of medical access or transportation barriers, or who are anxious or fearful about getting a colonoscopy.
“Colorectal cancer is a highly preventable disease, but it’s far too common,” Limberg says. “We estimate that between 50 million and 60 million people have not been tested or are under-tested, meaning that even if they have been tested in the past, they are past their deadline.”
A man without a colon is tested for colon cancer.
Smith said she received a letter included with the kit that said the test was “recommended by your provider.” “The way this letter was worded really confused us. … We didn’t know if it meant my insurance company or my doctor.”
Smith ultimately followed the testing instructions and mailed the completed test kit to the testing facility. He thought the doctor might have ordered tests to check the small intestine, which was still intact.
A few weeks later, “they called me and said, ‘You have genetic markers for cancer,'” Smith said. “When you hear ‘cancer,’ you’re like, oh, I should look into this.”
Smith said Gunaratnam’s doctors recommended getting an endoscopy to check for signs of throat or stomach cancer. Cologuard tests the entire gastrointestinal tract for blood and abnormal DNA, Gunaratnam said. Doctors performed an endoscopy to rule out cancer anywhere in Smith’s gastrointestinal tract.
There were no signs of cancer. They determined that Cologuard likely picked up the blood from a stoma bag used to remove waste from his body.
Mr Gunaratnam said Mr Smith should not have taken the Cologuard test because he does not have a colon. But the doctor said he needed a follow-up scope to check for cancer.
Gunaratnam said his practice “forced me to take that test because I didn’t want to miss anything.” “Once you open a can of worms, you have to follow through.”
Smith said it took about a month to schedule and complete the endoscopy after the Cologuard test. He said he was feeling stressed and anxious at the time. He didn’t want to upset his wife, but thought about the cancer diagnosis and the possibility of his own death.
He said endoscopy is “not comfortable because you have to put an endoscope down your throat and look around.”
He was relieved that the endoscopy showed no signs of cancer, but his relief turned to anger. He wondered why the Cologuard test was mailed to him in the first place.
“It kind of pissed me off. It pissed me off,” Smith said.
Gunaratnam said the test illustrates the potential pitfalls when insurance companies and testing companies don’t know the details of a patient’s full medical history.
“This has failed on so many different levels,” Gunaratnam said. “It’s really bad for insurance companies and publicly traded companies (Exact Sciences) to influence public policy and public health by trying to push testing. It’s wrong.”
Cologuard relies on a list of insurance companies and health systems
Limburg said the company relies on health insurance companies’ lists of eligible patients and health systems with such “fill-in-the-gap” testing programs.
He said Exact Sciences does not have access to patient health records, so it cannot determine when individuals like Mr. Smith should not have been tested.
“We don’t have the level of detail that the plans and payers have,” Limberg said, adding that the company would revise the list if it found out who should not be tested. He added that the company tells consumers they have the right to opt out of testing. The company will also alert a consumer’s primary care physician if they have such information, he said.
“We are doing everything we can to ensure that the patients receiving the Cologuard kits are the right patients,” Linberg said.
Limburg said the home test will be prescribed by a health insurance company or a doctor or health care provider identified by Exact Sciences’ telemedicine partner, Recuro Health.
Smith’s insurance company, Blue Cross Blue Shield of Minnesota, said mailing the Cologuard test to eligible customers is a “cost-effective, time-saving and minimally invasive colorectal cancer screening solution.”
The insurer said it has identified fewer than 900 customers who are eligible for such home inspections. Blue Cross sent information about the screening program to customers’ health care providers. The insurer also sent information directly to consumers, including instructions to opt out if they did not wish to receive the kit, the company said.
According to Exact Sciences, the nation’s top 10 largest private insurance companies have at least one health plan participating in a program to mail Cologuard kits to consumers.
While some may find it perplexing that insurance companies are sending out letters urging consumers to get tested, other advocates say they would welcome some awareness about colon cancer testing.
Andrew Siegel, CEO of the World Colon Cancer Society, said screening options are important because some consumers want to avoid invasive colonoscopies.
“The most effective cancer screening tests are those that patients themselves take,” Siegel said. “They all work. Just pick one and run.”
Email consumer health reporter Ken Alltucker at alltuck@usatoday.com..
