Cologuard® Gains FDA Approval For Use In Younger Americans, Ages 45 To 49

MADISON, Wis., Sept. 23, 2019 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS) 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 cancer[iv] 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-risk individuals. Cologuard uses a biomarker panel which analyzes a person's stool sample 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 tackle the 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 unscreened populations."

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.

Media Contact:
Cara Connelly, [email protected], 614-302-5622

Investor Contact: 
Megan Jones, [email protected], 608-535-8815

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 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.

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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] Itzkowitz SH, Incremental advances in excremental cancer detection tests. JNCI. 2009;101(18)1225-1227.

[v] Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69:7-34.

[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.

SOURCE EXACT SCIENCES CORP

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