Modeling Data Supports Cologuard Use Every Three Years
Performance over Three-Year Interval Supported by CISNET Modeling and Real-World Adherence Considerations
23 Feb, 2016, 06:36 ET
MADISON, Wis., Feb. 23, 2016 /PRNewswire/ -- A peer-reviewed analysis of the modeling data relied upon by the U.S. Preventive Services Task Force (USPSTF) when developing its draft colorectal cancer screening guidelines concludes that screening with Exact Sciences Corp.'s (Nasdaq: EXAS) Cologuard test on a three-year interval is equal or superior to screening with fecal blood tests on a two or three-year interval. The USPSTF considered fecal blood tests on an annual basis. The modeling did not consider adherence when evaluating screening outcomes despite significant evidence that adherence to annual screening is unrealistic in clinical practice.
"Given that annual screening for colon cancer is rarely achieved, it's critical to use real-world experience when evaluating non-invasive screening test performance," said Kevin Conroy, chairman and CEO of Exact Sciences. "Recently-published data reveal that only three in a thousand people were adherent with colorectal cancer screening using annual fecal blood tests during a continuous 10-year period. With the intermittent nature of screening, the high sensitivity of Cologuard provides an assurance that when non-invasive screening is done, 92 percent of cancers will be detected."
The analysis of screening intervals was published in the American Journal of Managed Care. It compared Cologuard with both fecal immunochemical testing (FIT) and high-sensitivity fecal occult blood testing (hsFOBT) using the CISNET modeling relied upon by the USPSTF when making its draft recommendations for colorectal cancer screening in October 2015. The three colorectal cancer screening models used described the impact of non-invasive screening strategies on colorectal cancer incidence, related mortality, life-years gained, colonoscopy volume and associated complications, and test efficiency and harms. The analysis highlights:
- Only Cologuard used every three years generated greater than 90 percent of the life-years gained with screening colonoscopy in at least one of the models, in comparison with fecal blood tests used every two or every three years;
- Cologuard has significantly higher sensitivity for cancerous and precancerous lesions than fecal blood testing;
- Cologuard could be of great utility in irregularly screened patients and in allowing longer test intervals and lower health system screening-process burdens.
Cologuard is the only FDA-approved colorectal cancer screening test. It is reimbursed by Medicare every three years and is included in the American Cancer Society guidelines for use every three years.
The analysis is available online from the American Journal of Managed Care. Two of the authors conducting the analysis are employees at Exact Sciences Corp. Dr. Bernard Levin is a member of Exact Sciences Scientific Advisory Board and has received consulting fees from the company, though not for this publication.
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.
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