MADISON, Wis., July 13, 2016 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) announced that the National Committee for Quality Assurance (NCQA) has proposed to broaden the 2017 Healthcare Effectiveness Data and Information Set (HEDIS) quality measures for colorectal cancer screening to include Cologuard® on a three-year schedule.
"Inclusion in the HEDIS quality measures is an important milestone toward Cologuard becoming a standard of care for colon cancer screening," said Kevin Conroy, chairman and CEO of Exact Sciences. "Physicians, health systems and insurers would receive quality credit for using this patient-friendly screening option, which we believe will hasten its adoption."
More than 90 percent of America's health plans measure quality based on HEDIS. Likewise, the CMS Star Ratings, which guides quality measures for Medicare Advantage plans, are directly impacted by HEDIS. The proposal to broaden the colorectal cancer screening measure is subject to a 30-day public comment period, which opened today. NCQA's effort would align HEDIS with the preeminent colorectal cancer screening recommendations, including those of the U.S. Preventive Services Task Force. The HEDIS 2017 quality measures will be used to audit the 2016 performance of physicians, health systems and insurers.
"Primary care physicians and health plans are increasingly financially incentivized to demonstrate improvements in quality as measured by data, such as colon cancer screening rates," Mr. Conroy said. "Cologuard's inclusion in HEDIS is an important step toward helping them achieve better quality scores."
The U.S. Preventive Services Task Force recently included Cologuard in its colorectal cancer screening recommendation statement, which resulted in NCQA's proposed mid-year update in order to align the HEDIS measures with the Task Force's recommendation statement. Cologuard is also the only colorectal cancer screening method that is supported by a built-in compliance service designed to actively encourage patients to complete their physician-ordered screening.
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 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 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 the potential inclusion of Cologuard in the National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS), CMS's Five-Star Quality Rating System, or other quality measures, 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 health care providers; the willingness of health insurance companies and other payors to 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 without limitation the Affordable Care Act, or changes in healthcare pricing, coverage and reimbursement; recommendations, guidelines and/or quality-of-care metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society and NCQA regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative and licensing arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; the impact of our nationwide television advertising campaign; 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 Reports 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.
Senior Director, Corporate Communications
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SOURCE EXACT SCIENCES CORP