New Prospective Data Demonstrate Low False-Positive Rate for Screening Average-Risk People Age 45-49 for Colorectal Cancer with Cologuard®

Cologuard's high specificity would help minimize risk and cost from unnecessary diagnostic procedures in this age group

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Jan 12, 2021, 14:45 ET

MADISON, Wis., Jan. 12, 2021 /PRNewswire/ -- Exact Sciences Corp. (Nasdaq: EXAS) announced data published today in Cancer Prevention Research, a Journal of the American Association for Cancer Research, that expands on foundational clinical study findings to include a key younger population. Study results show that among average-risk adults between the ages of 45 and 49 Cologuard® (mt-sDNA) demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions or negative findings at colonoscopy and 96.3% in only those with negative colonoscopy findings. These analyses support potential risk mitigation and cost prevention due to unnecessary diagnostic procedures when using Cologuard as a colorectal cancer screening tool in this younger population.

Cologuard is a U.S. Food & Drug Administration (FDA)-approved, non-invasive stool DNA test for colorectal cancer for average-risk people. In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.

"These new data support the critical role an effective, non-invasive option like Cologuard plays in screening people ages 45 to 49," said Kevin Conroy, chairman and CEO of Exact Sciences. "Cologuard may appeal to this younger screening population because they can collect sample at home, without missing work or undergoing bowel prep and anesthesia, and only those patients with a positive Cologuard will require a diagnostic colonoscopy."

In a previously published, large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers, including 94% in stages I and II. Specificity for this over 50 population was 87%.

Colorectal cancer is the second leading cause of cancer death for men and women in the United States, in part because many cancers go undetected until later stages when treatment is less effective. Colorectal cancer can be prevented or detected early through screening; however, approximately 44 million Americans remain unscreened, including an estimated 19 million between ages 45 and 49.

The incidence of colorectal cancer in people under the age of 50 has dramatically increased in the last 20 years. Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50. More than half of these cases were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low.

"This study is among the first to evaluate the use of a colorectal cancer screening method in patients between the ages of 45 and 49," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "The American Cancer Society guidelines and the 2020 draft United States Preventive Services Task Force (USPSTF) guidelines now say that screening should begin at 45, and these data support the use of Cologuard as a first line screening option."

The prospective study included 816 evaluable participants who all completed a Cologuard test and underwent a colonoscopy. Participants were enrolled at 31 sites in the United States from November 2018 through June 2019. They completed Cologuard, followed by a screening colonoscopy within approximately 60 days of enrollment. Participants collected their sample for the Cologuard test prior to doing any bowel preparation necessary for the colonoscopy. All colonoscopies were performed blinded to the Cologuard results.

Specificity was the primary outcome and was measured in participants without colorectal cancer or advanced precancerous lesions and in the subgroup of participants with negative colonoscopic findings. None of the study participants had colorectal cancer, 49 had advanced precancerous lesions, 253 had non-advanced adenomas and 514 had negative colonoscopies. Specificity did not differ between men and women.

Media Contact:
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About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX^®, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against 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 in adults 50 years of age or older 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 Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have 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.

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 concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. 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.

SOURCE EXACT SCIENCES CORP