MADISON, Wis.--(BUSINESS WIRE)--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.
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.
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