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.
About Cologuard
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.
Certain statements made in this presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this presentation regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales and marketing efforts, expectations concerning payor reimbursement and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and health care providers; the willingness of health insurance companies and other payors to reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening products and services; the effects of any healthcare reforms or changes in healthcare pricing, coverage and reimbursement; recommendations, guidelines and/or quality-of-care metrics issued by various organizations such as the U.S. Preventive Services Task Force , the American Cancer Society and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative and licensing arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
CONTACT:
JP Fielder
680 210 5220
jfielder@exactsciences.com
Logo - http://photos.prnewswire.com/prnh/20160108/320353
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/modeling-data-supports-cologuard-use-every-three-years-300224438.html
SOURCE EXACT SCIENCES CORP