MADISON, Wis., Feb. 27, 2019 /PRNewswire/ -- In less than five years, more than two million Americans have screened for colorectal cancer with Cologuard. Exact Sciences Corp., which created the groundbreaking product with Mayo Clinic, processed more than one million Cologuard tests in the last year alone. Nearly half of the people screened with Cologuard had not previously been screened for colorectal cancer, the second leading cause of cancer death in the United States.ⁱ

"Cologuard is changing how Americans get screened for colorectal cancer and, importantly, helping many people do so for the first time," said Kevin Conroy, chairman and CEO of Exact Sciences. "Reaching this milestone, just a year after the first million patients screened with Cologuard, means more patients and healthcare providers are empowered by early detection when colorectal cancer is more treatable."

Since 2014, more than 150,000 healthcare providers have ordered Cologuard. Based on Cologuard's detection rate for early stage colorectal cancer and precancerous polyps, Exact Sciences estimates the test may have helped detect as many as 9,400 early-stage cancers and approximately 64,000 pre-cancerous polyps.ⁱⁱ

"With the support of our unique 24/7 customer care team, the number of people being screened for colorectal cancer is increasing," said Mark Stenhouse, president of Cologuard. "In 2019, we are focused on accelerating this momentum with the addition of a second lab and growing workforce, our partnerships with Pfizer and Epic, and an ongoing commitment to providing excellent customer care."

This announcement comes ahead of National Colorectal Cancer Awareness Month, which is celebrated annually in March. Despite colorectal cancer being considered the most preventable form of cancer, one in three Americans age 50 and older are not up-to-date with recommended screening.ⁱⁱⁱ When colorectal cancer is detected in Stage I, about 90 percent of patients survive five-years, and the removal of precancerous lesions can prevent the disease. Only about 14 percent of patients survive five-years when the disease is detected in Stage IV.^iv

To increase awareness for the importance of colorectal cancer screening and early cancer detection during National Colorectal Cancer Awareness Month, the 2019 PGA TOUR Champions Cologuard Classic will be played February 27 - March 3 at Omni Tucson National Resort. Tournament proceeds benefit colorectal cancer research and youth athletic programs in Southern Arizona. For more information or tournament tickets, visit www.cologuardclassic.com.

Cologuard is intended for use by adults age 50-plus at average risk for colorectal cancer. To learn more about Cologuard visit www.cologuardtest.com.

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 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.

About Cologuard
Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.

Cologuard is not for high risk individuals, including those with a history of colorectal cancer and advanced adenoma, a family history of colorectal cancer, IBD or certain hereditary syndromes. Positive Cologuard results should be referred to diagnostic colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. 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. 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 healthcare reform law, rule, order, interpretation or policy; 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.

ⁱ Centers for Disease Control and Prevention. Colorectal cancer statistics. Centers for Disease Control and Prevention website. https://www.cdc.gov/cancer/colorectal/statistics/index.htm. Updated June 12, 2018. Accessed January 30, 2019.
ⁱⁱ Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297
ⁱⁱⁱ Centers for Disease Control and Prevention. Vital signs: colorectal cancer tests save lives. Centers for Disease Control and Prevention website. http://www.cdc.gov/vitalsigns/colorectalcancerscreening. Updated November 7, 2013. Accessed January 17, 2019.
^iv National Cancer Institute. Cancer stat facts: colorectal cancer. National Cancer Institute website. https://seer.cancer.gov/statfacts/html/colorect.html. Accessed January 30, 2019.

CONTACT: Steph Spanos, [email protected] / 608-800-6648  

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