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Exact Sciences And Mayo Clinic Initiate 150,000 Patient, 7-Year Study To Evaluate Real-World Impact Of Cologuard®

Data from Prospective, Observational Study will Strengthen Clinical Evidence and Support Continued Cologuard Adoption

MADISON, Wis., Oct. 14, 2019 /PRNewswire/ -- (EXAS) – Exact Sciences Corp. today announced that, in collaboration with Mayo Clinic, it has initiated the Voyage study to generate evidence of the real-world impact of Cologuard on colorectal cancer screening, incidence, and mortality rates. Voyage is a prospective, observational study designed to enroll more than 150,000 people with a valid Cologuard order and follow them for at least seven years to evaluate clinical outcomes. Voyage is one of the largest prospective, observational colorectal cancer screening studies ever conducted.

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

More than 50,000 Americans die from colorectal cancer each year, making it the second-leading cancer-killer in the U.S.i Screening can save lives by preventing the disease or detecting it early.ii Still, more than an estimated 40 percent of the 106 million eligible Americans aren't up-to-date with the American Cancer Society's colorectal cancer screening guidelines.iii Cologuard, the only FDA-approved, at-home colorectal cancer screening test, has the potential to help improve screening rates in this population.

Cologuard is 92 percent sensitive for colorectal cancer, 69 percent sensitive for high-risk pre-cancer, and backed by a nationwide user-navigation system, providing 24/7 support to improve compliance with screening. Over the past five years, Cologuard has helped screen more than 3 million people for colorectal cancer, with nearly half of surveyed users reporting never being screened previously. Today, Cologuard is widely accessible with 95 percent of users paying nothing out of pocket for the test. 

"We applaud efforts to gather evidence on the performance and outcomes of colorectal cancer screening," said Paul Limburg, MD, MPH, AGAF, Exact Sciences chief medical officer. "This study will be instrumental in further demonstrating the clinical utility of Cologuard, a highly accurate, non-invasive screening option, in our collective effort to reduce the colorectal cancer burden."

Cologuard performance was initially validated in a 10,000 patient, prospective trial published in The New England Journal of Medicine in 2014. Voyage will provide additional, real-world evidence to demonstrate the clinical impact of Cologuard and help position it as standard-of-care in colorectal cancer screening.

About the Voyage Study
The Voyage study is a prospective, observational study to examine patient use of health services and related health outcomes among a cohort of average-risk adults prescribed Cologuard for routine colorectal cancer screening. The purpose of the Voyage study is to evaluate the real-world impact of Cologuard on colorectal cancer screening, incidence, and mortality rates. The study is designed to enroll over 150,000 adults with a valid Cologuard order and follow them for at least 7 years following the day of first enrollment. The Voyage study will be led by Mayo Clinic and enroll participants nationwide.

More information about the Voyage study can be found at NCT04124406.

[i] American Cancer Society, Cancer Facts & Figures 2019
[ii] Bibbins-Domingo K et al. for US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2016;315(23):2564-2575.
[iii] CDC NHIS survey results as published in the CDC's MMWR between 2006 and 2017

Investor Contact:
Megan Jones, meganjones@exactsciences.com, 608-535-8815

Media Contact:
Cara Connelly, cconnelly@exactsciences.com, 608-284-5735

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. 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.

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 (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative).

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

Forward-Looking Statements
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," "would," "could," "seek," "intend," "plan," "goal," "project," "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 payer 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; our ability to meet demand for our products and services; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition from other cancer screening and diagnostic products and services; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; 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 ability to effectively utilize strategic partnerships, such as our Promotion Agreement with Pfizer, Inc., and acquisitions; 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 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.

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