COLOGUARD® GAINS FDA APPROVAL FOR USE IN YOUNGER AMERICANS, AGES 45 TO 49
Stool DNA test offers a sensitive, noninvasive, at-home option to screen for colorectal cancer, second deadliest cancer in U.S.
MADISON, Wis. –September 23, 2019 (NASDAQ: EXAS) – Exact Sciences Corp. announced today that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication for ages 50 and older. The decision comes at a critical time when the incidence of colorectal cancer is on the rise among American adults under the age of 50.i
Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.i Among these cases, more than half were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low. About one out of 10 people with stage IV colorectal cancer survive beyond five years.ii,iii
The American Cancer Society (ACS) responded to the growing trend of colorectal cancer in younger patients in May 2018 when it updated its colorectal cancer screening guidelines to include people between the ages of 45 to 49.i The prior ACS recommendation called for screening to begin at age 50.vii
Colorectal cancer is considered the most preventable, yet least prevented form of canceriv and is the second deadliest cancer in the U.S.v Regular screening is crucial because colorectal cancer is more treatable when detected in its earlier stages.v
The label expansion, or broadening of the population for whom Cologuard is FDA- approved, provides a new, sensitive, at-home stool-based screening choice for the approximately 19 million average-risk people in the U.S. ages 45 to 49.vi
“About three million people have been screened for colorectal cancer with Cologuard, with nearly half of those surveyed saying they were previously unscreened. With the FDA now approving the use of Cologuard for this vulnerable 45-49 age group, we are giving health care providers a sensitive, noninvasive option that has the potential to help combat the rise of colorectal cancer rates among this younger group of people,” said Kevin Conroy, chairman and CEO of Exact Sciences.
Backed by strong science and robust clinical research in collaboration with Mayo Clinic, Cologuard is a stool DNA-based colorectal cancer screening test for average-
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risk individuals. Cologuard uses a biomarker panel which analyzes a person’s stoolsample for 10 DNA markers, as well as blood in the stool (hemoglobin).
“The alarming rise in incidences of colorectal cancer for those under 50 is creating a sense of urgency,” said Anjee Davis, President of Fight Colorectal Cancer. “To tacklethe need for increased awareness and screening across the country, we must work together with advocacy groups, industry innovators, insurance companies and health care providers. There is a need to educate the public about colorectal cancer screening and the array of reliable screening options. Expanding the screening age to 45 for Cologuard provides an additional tool to reach the unscreenedpopulations.”
In an effort to combat the colorectal cancer screening gap, Exact Sciences designed a one-of-a-kind, nationwide user-navigation system that provides 24/7 phone and online support to help people through the process of collecting and returning their samples. This approach combines multiple industry best practices to offer a vital tool in the collective efforts to increase colorectal cancer screening.
“The medical and scientific communities agree that rising rates of colorectal cancer in younger adults must be addressed, and we support efforts to gather evidence on the impact of screening in younger populations,” said Paul Limburg, MD, MPH,AGAF, Chief Medical Officer of Exact Sciences and Mayo Clinic gastroenterologist. “As research progresses, we must offer screening options to people that may already have or will develop colorectal cancer and pre-cancers, aiming to increase screening rates and halt the rise of colorectal cancer in younger Americans.”
Exact Sciences is committed to working across the health care delivery system to ensure those seeking an at-home, noninvasive screening test have access to all options and is actively working with payer partners to expand coverage to include this critical screening population.
Cologuard is available to appropriate patients through their health care provider. For more information, visit www.CologuardTest.com or call 1-844-870-8870.
Cara Connelly, firstname.lastname@example.org, 614-302-5622
Media Contact: Investor Contact:
Megan Jones, email@example.com, 608-535-8815About Exact Sciences Corp.
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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.
Cologuard was first 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 as a recommended option for adults over the age of 50 by the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016).
Cologuard is indicated to screen adults of either sex, 45 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, including those with a history of colorectal cancer and adenomas, a family history of colorectal cancer, IBD, or certain hereditary syndromes. 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. The clinical validation studies were conducted in patients over 50 years of age. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.
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
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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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i Wolf A, Fontham E, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68:250-281.
ii Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;0:1-8.
iii Lansdorp-Vogelaar I, v Ballegooijen M, Zauber AG et al. Effect of Rising Chemotherapy Costs
on the Cost Savings of Colorectal Cancer Screening. J Natl Cancer Inst 2009;101:1412-1422.iv
vi United States Census Bureau. www.census.gov. Accessed September 10, 2019.
vii Smith RA, Andrews KS, Brooks D, et al. Cancer screening in the United States, 2017: A review of current American Cancer Society guidelines and current issues in cancer screening. CA: A Cancer Journal for Clinicians, 67: 100-121.
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