Jeff Smith was dumbfounded when he received a colon cancer screening kit in the mail.
The 68-year-old Minnesota man hadn’t asked for the Cologuard test, and his doctor hadn’t mentioned anything about it. And why in the world would he need such a test? Smith has lived most of his life without a colon. As a child, he had ulcerative colitis, an inflammatory bowel disease. Doctors removed his colon.
Smith’s experience, which included additional uncomfortable testing after he completed the kit, has some doctors worried about the idea of mailing tests to patients without consulting their doctors first. Early detection of colon cancer is crucial – it’s the second-leading cause of cancer deaths in the United States, with nearly 53,000 people projected to die from it in 2025, according to the American Cancer Society.
But the disease is highly treatable if caught early; screening is recommended for adults ages 45 to 75 at average risk. Yet nearly 1 in 3 eligible adults are not up to date on colon cancer screening.
Consumers increasingly have testing options beyond the once-a-decade colonoscopy. Tests that can detect signs of the disease in a person’s stool are available, and the Food and Drug Administration approved a blood test in 2024. Exact Sciences, the company that markets the Cologuard test, teamed up with health insurance companies and health systems to send kits to the homes of eligible people who have never been screened for colon cancer or are past due.
Some doctors not affiliated with Exact Sciences are raising questions about the home screening program. They worry that in some cases, doctors are being cut out of the decision-making process, which can lead to inappropriate testing, they say − much like what Smith had to deal with.
Naresh Gunaratnam, one of Smith’s doctors, is a gastroenterologist and president of the Digestive Health Physician Association, which represents nearly 3,000 doctors specializing in digestive care. He said he worries such mail-home tests can be prescribed inappropriately and create angst and worry among patients.
“You’re destroying the doctor-patient relationship,” Gunaratnam said.
Paul Limburg, chief medical officer of screening for Exact Sciences, said the company partnered with several major insurance companies and health systems to ship Cologuard kits to the homes of people who are due for screening.
Health insurance plans send lists of eligible patients to Exact Sciences, which completes its own checks to verify someone is due for screening. A person must not have been screened with Cologuard within the past three years. High-risk patients who carry a genetic condition that puts them at higher risk of colon cancer might need more frequent testing than someone at average risk.
Limburg cited Centers for Disease Control and Prevention-published research on another colon cancer test mailed to homes of people due for screening. The CDC research examined community health centers that mailed fecal immunochemical tests, or FIT tests, to patients.
Cologuard and FIT tests are less expensive and easier to complete than a colonoscopy. But a positive test on the results might require a follow-up colonoscopy.
Limburg said the program is designed to reach people who have not been screened because of lack of medical access or transportation barriers − as well as those who are anxious or fearful over getting a colonoscopy.
“Colorectal cancer is a highly preventable disease, but it’s way too common,” Limburg said. “We estimate there’s between 50 and 60 million people who are unscreened or under-screened, meaning that even if they’ve been screened in the past, they’re overdue.”
Smith received a letter that accompanied the kit that said the test was “recommended by your provider,” Smith said. “The way that this letter was worded, it really confused us. … I didn’t know whether that meant my insurance company or if it meant my doctor.”
Smith ended up following the test’s instructions and mailed the completed test kit to a laboratory. He reasoned his doctor might have ordered the test to check his small intestine, which is still intact.
Weeks later, “they called me and said, ‘You have genetic markers for cancer,’” Smith said. “You hear ‘cancer’ and, whoa, I’d better check this out.”
Smith said a doctor who is part of Gunaratnam’s practice recommended he get a scope to check for signs of throat or stomach cancer. Cologuard checks for blood or abnormal DNA in the entire digestive tract, Gunaratnam said. The doctor performed an endoscopy on Smith to rule out cancer anywhere in his digestive tract.
There were no signs of cancer. They determined Cologuard likely picked up blood from his ostomy bag used to clear waste from his body.
Gunaratnam said Smith never should have received the Cologuard test because he doesn’t have a colon. But the doctor said the follow-up scope was necessary to check for cancer.
His practice “was forced to do that test because I didn’t want to miss something,” Gunaratnam said. “Once you’ve opened up that can of worms, you’ve got to follow through.”
Smith said it took about a month to get the scope scheduled and completed after his Cologuard test. He said he was stressed and anxious during that time. He didn’t want to upset his wife, but he thought about a possible cancer diagnosis and his mortality.
He said the endoscopy “isn’t a comfortable thing, because they put a scope down your throat and look around.”
He was relieved the endoscopy did not find any signs of cancer, but relief turned to anger. He questioned why the Cologuard test was mailed to him in the first place.
“I felt kind of pissed. I was angry,” Smith said.
Gunaratnam said the test shows the potential pitfalls when insurance and testing companies might not be familiar with a patient’s full history.
“This failed on so many different levels,” Gunaratnam said. “When insurance companies and a publicly traded company (Exact Sciences) affect public policy and public health because they’re trying to promote their test, that’s really bad. That’s wrong.”
Limburg said the company relies on list of eligible patients from health insurance companies as well as health systems that have such “gap closure” screening programs.
He said Exact Sciences doesn’t have access to the patients’ health records, so they are unable to identify when individuals, such as Smith, should not have received a test.
“We don’t have the level of detail that the plans and the payers have,” said Limburg, who added the company modifies the list if it discovers a person should not be screened. He added the company informs the consumers they have the right to opt out of testing. The company also alerts consumers’ primary care doctors if they have such information, he said.
“We’re doing everything that we can to make sure that the patients who receive the Cologuard kit are the appropriate ones,” Limburg said.
Limburg said the home tests are prescribed by a doctor or health provider identified by the health insurer or Exact Sciences telehealth partner, Recuro Health.
Smith’s insurance provider, Blue Cross Blue Shield of Minnesota, said mailing Cologuard tests to eligible customers is “a cost-effective, timesaving and minimally invasive screening solution for colorectal cancer.”
The insurer said it has identified fewer than 900 customers who would be eligible for such home screening. 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 want to receive the kit, the company said.
Exact Sciences said the nation’s top 10 largest private insurers have at least one health plan participating in the program to mail Cologuard kits to consumers.
Though some might be confused by insurance companies sending letters urging consumers to get screened, some advocates say any awareness about colon cancer screening is welcome.
Andrew Spiegel, CEO of the Global Colon Cancer Association, said screening options are important because some consumers want to avoid an invasive colonoscopy.
“The most effective cancer screening test is the one that the patient will get done,” Spiegel said. “They all work. You just have to pick one and do it.”
Email consumer health reporter Ken Alltucker at alltuck@usatoday.com.