INSET BELOW: Dr. Matthew D'Alessio; Dr. Andrea Klemes; Dr. Robert Mellman; Dr. David Ahlquist.
By Linda Haase
Mention you’re going to get a colonoscopy, and you’ll usually get a look of sympathy. Perhaps an earful of some graphic jokes. Or, even worse, the story of someone else’s procedure that went horribly wrong.
Those of us of a certain age know that an invite to join AARP is usually followed by an appointment with a gastroenterologist for this all-important procedure. But between the all-day prep, the time away from work (and anything else not bathroom related) and the fear of anesthesia, it’s no wonder this is a test that many dread — or, regrettably, avoid.
Enter Cologuard, a new FDA-approved noninvasive screening test for colon cancer and pre-cancer. No prep needed. You don’t even need to leave home for this innovative test that detects blood in stools and altered DNA associated with colon cancer and pre-cancer.
The test is sent to a patient’s home. Users simply collect a stool sample and mail it to a lab using a prepaid and pre-addressed return label.
It’s designed for men and women 50 and older who are at average risk for colorectal cancer with no personal or family history of polyps or colorectal cancer, and have not been diagnosed with a condition that is associated with high risk for colorectal cancer (such as Crohn’s disease) and have no symptoms, including blood in stools or urine.
But is it a good alternative to a colonoscopy? Local doctors agree it has merit — but issue caveats.
“I think it a real break-through. One of the most important things we do in medicine is screen people for colorectal cancer,” notes Dr. Matthew D’Alessio, director of surgical oncology for the Bethesda Comprehensive Cancer Center. “Only 60 percent of people who should have a colonoscopy actually have one. However, the Cologuard test is new and nobody knows how it will perform in the real world. The standard is a colonoscopy, but this is a good alternative for people who are unwilling or unable to have a colonscopy. It’s better than nothing.”
During the Cologuard clinical study, 10,000 people of average risk for colon cancer in the United States and Canada were screened with the test. Although Cologuard found 92 percent of cancers, it did have some false negative or positive results. “The false negative results are the problem. This test could give people a false sense of security. They think that they don’t have colon cancer but they really do,” says D’Alessio. Those types of results, D’Alessio points out, don’t occur with a colonoscopy, which also has the advantage of allowing doctors to remove polyps found during the procedure.
Although D’Alessio is impressed with Cologuard’s clinical study that showed it found 92 percent of cancer (it also found 69 percent of precancerous polyps at greatest risk to progress to cancer), he notes that one of its downsides is that it doesn’t find small polyps. “Polyps start off as growths but become cancers if left alone,” he warns.
Cologuard, which was co-developed by the Mayo Clinic and Madison, Wisconsin-based Exact Sciences, is not available over the counter and costs $599 if not covered by insurance (it is, however, a Medicare approved test). Results are sent to the prescribing physician, and if the outcome is positive, you will need a colonoscopy.
Dr. Andrea Klemes, chief medical officer of Boca Raton-based MDVIP, is a proponent of the test.
“It is an innovative new test that is a significant advancement in colorectal cancer detection,” notes Klemes, who is board certified in internal medicine and endocrinology. “Many of the primary care physicians in our network have recommended and ordered the test, primarily because colorectal cancer is highly preventable with screening. This test will allow our patients who are 50 years and older and at average risk for colorectal cancer, an easy-to-use screening test which they can do in the privacy of their own home.”
And, she emphasizes, this just might convince some hesitant patients to get screened. “Twenty-three million Americans between ages 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cause of cancer-related deaths in the United States. This test should increase numbers of patients screened. If they are at high risk or if this test is positive, then a patient is referred for colonoscopy.”
The CDC claims that “if everyone age 50 or older had regular screening tests as recommended, at least 60 percent of colorectal cancer deaths could be avoided.”
Although Boca Raton-based gastroenterologist Dr. Robert Mellman says a colonoscopy “is the gold standard,” he does see some merit in Cologuard. It is “not a perfect test but it is a good one,” especially for someone who is healthy and absolutely refuses to have a colonoscopy or is unable to have one, he says.
Although he, too, lauds the high success rate for discovering cancer, the study’s sensitivity result for detecting advanced precancerous lesions was only 42 percent with DNA testing — and that worries him.
“Wouldn’t it just be better to have a colonoscopy where you could find and remove these polyps and prevent cancer?” asks Mellman, who has been practicing for 25 years and is on staff at Boca Raton Regional Hospital and Delray Medical Center.
Dr. David Ahlquist, a Mayo Clinic gastroenterologist and co-inventor of Cologuard, describes his discovery on the clinic’s website.
“Cologuard detection rates of early stage cancer and high-risk precancerous polyps validated in this large study were outstanding and have not been achieved by other noninvasive approaches,” he wrote. “It is our hope that this accurate and user-friendly test will expand screening effectiveness and help curb colorectal cancer rates in much the same way as regular Pap smear screening has done for cervical cancer.”
Getting the word out about colorectal cancer is vital, says D’Alessio, who often speaks to community groups about the issue. “We need to take the fear factor out of this. If you have it you want to know about it and you want to know about it sooner than later. We have an extremely high rate of success treating this disease and people need to know that,” says D’Alessio, who has offices in Boynton Beach and Delray Beach and serves as clinical assistant professor of surgery at Nova Southeastern University and Florida Atlantic University.
For more information, visit www.cologuardtest.com.
Linda Haase is a freelance writer on a quest to learn — and share — all she can about how to get and stay healthy. Reach her at lindawrites76 @gmail.com.
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