New Modeling Supports Using Cologuard® Every Three Years

Archimedes model used to conduct screening study in a virtual population of 200,000

Jan 11, 2016, 06:10 ET from Exact Sciences Corp.

MADISON, Wis., Jan. 11, 2016 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) today announced the publication of new modeling data in the peer-reviewed journal Clinical Colorectal Cancer that supports a three-year testing interval for Cologuard (sDNA), the company's FDA-approved, non-invasive, stool-DNA colorectal cancer screening test.

The modeling demonstrates that Cologuard used every three years compares favorably to colonoscopy every 10 years. The analysis shows a colorectal cancer incidence reduction of 57 percent and mortality reduction of 67 percent, compared to 65 and 73 percent, respectively, for colonoscopy every 10 years.

Using the sophisticated Archimedes cost-effectiveness model, the authors conducted a five-arm screening study in a population of 200,000 virtual individuals. The model compared the clinical effectiveness of sDNA screening to colonoscopy performed at 10-year intervals and to no screening during a 30-year period.

"We are very pleased that this robust modeling supports a three-year interval for screening with Cologuard, which is consistent with the Medicare coverage policy for Cologuard and the American Cancer Society's colon cancer screening guidelines," said Kevin T. Conroy, chairman and CEO of Exact Sciences. "When a three-year Cologuard interval is modeled, Cologuard produces reductions in colon cancer incidence and related mortality similar to colonoscopy every 10 years. These significantly improved outcomes can be achieved at a reasonable cost for the millions of American who will not participate in colonoscopy screening, while providing less burden to patients, providers and health systems than annual screening."

The modeling also finds that Cologuard is cost effective. At an assumed average price of $600 per test and an assumed average cost of $1,500 for colonoscopies following a positive test, three-year sDNA screening costs $11,313 per quality adjusted life year compared with no screening.  By comparison, triennial cervical and biennial breast cancer screening have been reported to cost $15,500 and $30,000 per quality adjusted life year, respectively, compared with no screening.

The modeling in the peer-reviewed journal Clinical Colorectal Cancer is available here.

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 some 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 guidelines of 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 news release 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 news release 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 reductions in colorectal cancer incidence and mortality, expected cost effectiveness, 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; the acceptance of our products 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 procedures; our ability to maintain regulatory approvals and comply with applicable regulations; our success establishing and maintaining collaborative and licensing arrangements; recommendations and/or guidelines issued by the U.S. Preventive Services Task Force, the American Cancer Society, or other organizations regarding cancer screening or our products and services; our ability to successfully develop new products; 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:
J.P. Fielder
Exact Sciences Corp.
jpfielder@exactsciences.com
608-210-5220

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SOURCE Exact Sciences Corp.



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