A new molecular diagnostic approved by Medicare and Medicaid is among the first non-invasive alternatives to colonoscopies, a potential boon for patients and payers but also a new piece of the personalization puzzle to manage.
Shares of Madison, Wisconsin-based Exact Sciences soared 36 percent on Friday, October 10th, after the biotech announced that its Cologuard stool-based colon cancer test received national coverage approval from the Centers for Medicare & Medicaid Services.
The at-home screening tool is the first Medicare-covered stool-based DNA test for detecting colon cancer and pre-colon cancer, approved once every three years for beneficiaries ages 50 to 85 who are asymptomatic and at average risk of the disease, with no family history or presence of inflammatory bowel diseases.
"Colorectal cancer is often considered the most preventable, yet least prevented cancer due to the lack of patient compliance with screening," Kevin Conroy, Exact Sciences president and CEO.
It is the second-leading cause of cancer deaths in the U.S. but it does have a 90 percent five-year survival rate when the disease is detected in early stages.
The key populations targeted for the Cologuard are potentially huge -- those who'd prefer to opt out of colonoscopies because of discomfort with the nature and risks of the procedures.
Although colonoscopies are guaranteed to those 50 and older with no cost-sharing as a preventative service, some 23 million Americans between 50 and 75 are are estimated to be missing guideline-recommended colonoscopies, Conroy noted.
As Medicare pricing is being decided for Cologuard, more private insurers, like Group Health Cooperative, are extending coverage for the test. Checking for blood as well as abnormal genetic expressions linked with cancer and polyps, the Cologuard test gives members a new choice that's easier and cheaper than colonoscopies and more accurate than other stool-based tests -- but still potentially confusing.
"This approval offers patients and physicians another option to screen for colorectal cancer," said Alberto Gutierrez, director of in vitro diagnostics and radiological health at the Food and Drug Administration, which okayed the test in August.
In a New England Journal of Medicine study of 10,000 patients, the test identified 92 percent of colorectal cancers in average-risk patients and 42 percent of polyps. That's a much higher accuracy rate than other non-DNA fecal immunochemical tests, but it also comes with a not insignificant false positive rate of 10 to 13 percent, which can set off a string of invasive diagnostics that can bring infection and complication risks.
While the U.S. Preventive Services Task Force's guidelines see colonoscopy as the gold standard in cost-effectiveness -- highly accurate and offering the ability to remove early stage disease in the same procedure -- the authors of the New England Journal study argued that the ability to take a simple stool test could also save lives, even with the higher false positive rate.
"Offering a choice among tests may improve uptake of screening," wrote Thomas F. Imperiale, MD, a medicine professor at Indiana University, and colleagues. "A noninvasive test with a high single-application sensitivity for curable-stage cancer may provide an option for persons who prefer noninvasive testing."
Among the questions now for researchers, patients and payers is whether younger individuals should be offered the diagnostic in an attempt to catch more late-stage cases among younger adults and more early-stages in general.