MADISON, Wis., Oct. 17, 2016 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) today announced that Cologuard® is now covered under TRICARE's preventive services policies for use every three years without patient coinsurance, copayments or deductibles. The update was made after TRICARE's review of its screening coverage policies to align them with the preventive services coverage mandate of the Affordable Care Act. TRICARE is the health care program of the U.S. Department of Defense, providing benefits to 9.4 million active-duty, reserve and National Guard personnel, veterans and their dependents.
"Cologuard is the ideal patient-friendly colon cancer screening option for America's active military and veterans to use at-home, ensuring they can efficiently be screened for the most preventable form of cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "Ensuring Cologuard is available to those who serve our country and their families with no out-of-pocket cost through TRICARE is a critical step toward increasing colon cancer screening."
TRICARE's advisory to Congress stated, "TRICARE will add coverage for additional preventive services in alignment with the United States Preventive Services Task Force (USPSTF) recommendations…. Collectively these changes also will revise TRICARE colon cancer screening provisions to allow coverage of stool DNA testing (e.g., Cologuard) once every 3 years beginning at the age of 50 for individuals at average risk of colon cancer based on the USPSTF's most recent recommendations. Coverage is effective June 21, 2016 for all beneficiaries."
"TRICARE's decision to cover Cologuard continues the growing trend of support for our non-invasive colon screening option following its A-rating by USPSTF," Conroy said. "This progress includes coverage for Medicare Advantage beneficiaries without out-of-pocket costs, inclusion in the preeminent quality measures, and coverage by a growing list of commercial insurers."
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 recommendations of the U.S. Preventive Services Task Force (2016) and the American Cancer Society's (2014) colorectal cancer screening guidelines. 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), the American College of Gastroenterology guidelines (2009) and the National Comprehensive Cancer Network (2016). 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 non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities 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. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales and marketing efforts, expectations concerning payor reimbursement and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; the willingness of health insurance companies and other payors to cover Cologuard and reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening products and services; the effects of any healthcare reforms, including the Affordable Care Act, or changes in healthcare pricing, coverage and reimbursement; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; and the other 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 Report(s) on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
CONTACT: JP Fielder, [email protected], 608-210-5220
SOURCE EXACT SCIENCES CORP