Earlier this month, the FDA approved Cologuard, the noninvasive stool DNA screening test for colorectal cancer from Exact Sciences. CEO Kevin Conroy shares what he sees as the test's place in colorectal cancer screening and its impact on the GI field. Question: Do you think Cologuard addresses a gap in colorectal cancer screening or is it a disruptive technology?
Kevin Conroy: I think it is somewhere in between. Roughly half of the millions of Americans deemed as average risk for colorectal cancer are not regularly screening with colonoscopy. Cologuard simply provides an opportunity to bring many, many more into the screening population, whether these are individuals who would not otherwise get screened or would be screened with an inferior test.
Q: What are the screening guidelines recommended for Cologuard?
KC: Presently, only the American College of Gastroenterology has a recommended interval for stool DNA testing, which is three years.The U.S. Preventative Services Task Force has yet to weigh in. But, Medicare did issue a proposed coverage rule for the test every three years. There is a 30 day public comment period open on the rule, and we can expect Medicare to issue a final decision 60 days after that.
Q: Is Cologuard a cost-effective colorectal cancer screening option?
KC: It is patient-friendly and it has a reasonable price point. It is easier to use for patients with certain co-morbidities, as well. First and foremost, it will encourage people to get screened.
Editor's note: A previous version of this article stated "Presently, only the American Gastroenterological Association has a recommended interval for stool DNA testing, which is three years." The AGA's most recent guidelines “Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline From the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology,” state “At this time, further research is needed to determine the interval between negative sDNA examinations. Based on current evidence, the appropriate interval is uncertain.”
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