Exact Sciences (Nasdaq: EXAS) issued the following statement today following the U.S. Preventive Services Task Force (USPSTF) draft recommendation statement for colorectal cancer screening.

USPSTF included Cologuard in the draft guidelines as an alternative screening test, along with CT colonography. The draft guidelines recommend an “A” rating for colorectal cancer screening starting at age 50 and continuing until age 75. Screening for individuals age 75 through 85 is graded a “C.” This approach represents a change from the 2008 recommendations, which assigned specific grades for different tests, including an “I” rating for stool-based DNA.

Cologuard is a non-invasive, FDA-approved colorectal cancer screening test that is covered by Medicare. Cologuard specifically and sDNA generally are included in the American Cancer Society and the U.S. Multi-Society Task Force screening guidelines, which include the American Gastroenterological Association, American College of Gastroenterolgy and American Society for Gastrointestinal Endoscopy.

Following USPSTF’s 30-day public comment period, a final recommendation is expected to be announced in 2016.

Exact Sciences Chairman and CEO Kevin Conroy stated, “We are pleased that Cologuard is included in the guidelines, and we look forward to working with USPSTF through its public comment process to optimize Cologuard’s position in the guidelines. Cologuard continues to see widespread and increasing utilization because of its demonstrated clinical performance and its broad appeal to patients and physicians.”

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.

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