In March, the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee unanimously voted to approve Cologuard, the stool-based DNA colorectal cancer screening test from Exact Sciences. Exact Sciences also published the results of its DeeP-C clinical study of the stool-based test in the New England Journal of Medicine. Co-author of the study Steven H. Itzkowitz, MD, director the GI fellowship program at Mount Sinai School of Medicine in New York, comments on the role this test could play in colorectal cancer screening and the affect it will have on the GI field.
Question: What do you think the results of this study mean for the field of gastroenterology and colorectal cancer screening?
Dr. Steven Itzkowitz: With a 92 percent sensitivity rate for detecting colon cancer, Cologuard — if approved — has the potential to be the most accurate non-invasive test and another important option in the arsenal of tools we have to detect colorectal cancer through screenings. Colon cancer is a preventable disease through regular screenings and it is an extremely curable disease, if detected early. Data show that screening rates improve when patients are offered a menu of screening options.
Q: Do you think FIT will still play a role in CRC screening?
SI: Yes, FIT remains an important non-invasive screening test for colon cancer. FIT tests are based on finding blood in the stool. Cologuard does this too, but also detects multiple DNA markers from cells that are exfoliated continuously into the stool. If a patient or physician wants to choose a non-invasive screening test, they should use the most accurate test available to them.
Q: How do you think Cologuard will affect the role of colonoscopy as the gold standard for colorectal cancer screening?
SI: Stool DNA screening, if approved, is not intended to replace the use of colonoscopy but rather will serve as another tool for clinicians to offer patients. If a patient receives a positive Cologuard result, the physician should encourage the patient to schedule a diagnostic colonoscopy.
Q: Do you think gastroenterologists will adopt Cologuard as a regular tool for CRC screening or for patients in need of a minimally invasive option?
SI: If approved, we hope that Cologuard will be made available as another screening option for patients among a menu of invasive and non-invasive options for screening. Physicians and patients need to discuss which option is best for them based on a variety of factors that are personal to each individual patient.
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