Cologuard® Coverage Expands with Updated Policies from HCSC and Florida Blue

PR Newswire

MADISON, Wis., Aug. 11, 2016 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) today announced that Health Care Service Corp. (HCSC), the nation's fourth largest health insurer, and Florida Blue recently updated their medical policies to cover Cologuard. With these policy updates, 80 million people are insured by commercial plans with positive medical policies regarding Cologuard. Including Medicare, Cologuard is now covered for 62 percent of its total target population.

"We are pleased that Cologuard's commercial coverage continues to broaden following its inclusion in the recently-updated U.S. Preventive Services Task Force colorectal cancer screening recommendations," said Kevin Conroy, chairman and CEO of Exact Sciences. "As health plans continue to update their coverage policies to include Cologuard, an increasing number of people have access to an innovative, non-invasive colorectal cancer screening option."

HCSC is the largest customer-owned insurer in the United States. Its subsidiaries include Blue Cross and Blue Shield plans in Illinois, Texas, Montana, New Mexico and Oklahoma. Under HCSC's updated policy, which is effective Aug. 15, 2016, Cologuard may be considered medically necessary for colorectal cancer screening once every three years for average risk patients who are not up to date with screening. The HCSC policy update states, "In 2016, the USPSTF updated their CRC screening guidelines to recommend the use of gFOBT, FIT, FIT-DNA (multitargeted stool DNA testing), colonoscopy, CT colonography, and flexible sigmoidoscopy for individuals ages 50 years to 75 years at average risk of colorectal cancer." To read HCSC's policy, click here.

According to Florida Blue's updated policy, "The use of an FDA approved fecal DNA test (e.g. Cologuard) meets the definition of medical necessity once every three years as a screening technique for members in whom colorectal cancer preventive screening is indicated (per USPSTF Colorectal Cancer Screening Grade A recommendation)." To read Florida Blue's policy, click 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 American Cancer Society's (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016). Stool DNA is included in the combined screening guidelines of the American Cancer Society/U.S. Multi-Society Task Force/American College of Radiology (2008) and the American College of Gastroenterology guidelines (2009).

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 the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.

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Contact:
J.P. FielderExact Sciences Corp.
[email protected]