CMS to cover the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer
MADISON, Wis.—(BUSINESS WIRE)— Exact Sciences Corp. (NASDAQ: EXAS) today announced that the Centers for Medicare & Medicaid Services (CMS) issued its final National Coverage Determination (NCD) for Cologuard, making it the first and only Food and Drug Administration (FDA) approved stool DNA test for the detection of colorectal cancer and precancer covered by Medicare. Coverage will go into effect immediately. Exact Sciences is still awaiting a preliminary pricing determination from CMS.
The NCD was based on the comprehensive review by the federal government agency as part of the FDA and CMS parallel review pilot program. Cologuard is the first medical device to receive FDA approval and a final NCD as part of the parallel review process.
"We are pleased with CMS' final coverage determination for Cologuard and would like to thank both CMS and FDA for giving Exact Sciences the opportunity to participate in the parallel review pilot program," said Kevin Conroy, President, CEO and Chairman ofExact Sciences. "Colorectal cancer is often considered the most preventable, yet least prevented cancer due to the lack of patient compliance with screening. CMS's decision to cover Cologuard will provide Medicare's 50 million patients with access to this accurate screening option."
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 cancer killer in the United States. For those whose cancer is detected at an earlier stage, the five-year survival rate can be greater than 90 percent.
Cologuard offers people 50 years and older who are at average risk for colorectal cancer an easy to use screening test which they can do in the privacy of their own home. Cologuard has been proven to find 92 percent of colorectal cancers in average risk patients with 87 percent specificity. Cologuard does not require medication, dietary restrictions or bowel preparation prior to taking the test. It is the first noninvasive screening test for colorectal cancer that analyzes both stool-based DNA and blood biomarkers to detect cancer and precancer.
The final NCD can be found online here: http://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=277
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.
Source: Exact Sciences Corp.
News Provided by Acquire Media