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Exact Sciences Announces Final Payment Decision for Cologuard® from the Centers for Medicare & Medicaid Services

EXAS | November 25, 2014

Exact Sciences Corp. (NASDAQ: EXAS) today announced that the Centers for Medicare & Medicaid Services (CMS) has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test. Cologuard is the first and only FDA-approved noninvasive stool DNA colorectal cancer screening test.

The final payment decision follows a comprehensive evaluation by the agency as part of a joint FDA and CMS parallel review pilot program. Cologuard is the first technology to gain approval through this program.

“CMS’ final payment decision represents a major milestone by providing 50 million Medicare patients access to this noninvasive colorectal cancer screening option,” said Kevin Conroy, president, CEO and chairman of Exact Sciences. “We thank FDA and CMS for giving Exact Sciences the opportunity to bring this new screening option to patients and physicians.”

Colorectal cancer is highly treatable with early detection through screening. However, 23 million Americans between 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cause of cancer-related deaths in the United States.

Available through a health care provider by prescription in all 50 states, Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy-to-use screening test that they can do in the privacy of their own home. The test found 92 percent of colorectal cancers in average risk patients with 87 percent specificity in the pivotal clinical trial that enrolled more than 10, 000 patients. Cologuard does not require medication, dietary restrictions or bowel preparation, and is included in the American Cancer Society’s Colorectal Cancer Prevention and Early Detection national guidelines.

For more information on Cologuard, visit www.CologuardTest.com or call 1-844-870-8870.

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About Exact Sciences Corp.

Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company focused on the early detection and prevention of colorectal cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Stool DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company's website at www.exactsciences.com, 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 and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, 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. Forward-looking statements in this news release may address the following subjects among others: statements regarding the sufficiency of our capital resources, our ability to secure favorable reimbursement rates from Medicare and other third-party payors, timing of our launch of a commercial product, our estimates of the available market size and our potential penetration, expected research and development expenses, expected general and administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those 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 urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.