Exact Sciences Presents New Data Reinforcing Performance of Cologuard®

Researchers to Present Real-World Findings at Digestive Disease Week® 2019

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May 17, 2019, 05:30 ET

SAN DIEGO, May 17, 2019 /PRNewswire/ -- New research from Exact Sciences and Mayo Clinic demonstrates the ability of Cologuard to both screen large patient populations and consistently help detect colorectal cancers and pre-cancers regardless of lesion location. The findings, presented at Digestive Disease Week (DDW) 2019, reinforce the role of Cologuard in improving colorectal cancer screening rates and patient outcomes.

Despite recent efforts to positively impact colorectal cancer screening rates in the US, one-in-three Americans ages 50 to 75 are not up to date with recommended screening.ⁱ New research suggests the Cologuard test can help screen more people. A review of more than 365,000 Medicare orders from Exact Sciences Laboratories, the sole-source lab for Cologuard, demonstrated high Cologuard compliance ⁱⁱ (71.1%) in the Medicare population. Further, more than nine-in-ten (90.7%) patients who completed the test did so within 60 days of receiving the order from their health care provider. During this window, the Exact Sciences Laboratories Patient Navigation System, which includes on-demand phone support, reminder phone calls, texts and emails, is most actively engaged. These findings (https://www.gastrojournal.org/article/S0016-5085(19)38398-2/fulltext) demonstrate Cologuard test features, coupled with its nationwide patient navigation system, can support high colorectal cancer screening compliance rates in the Medicare population.

"Colorectal cancer is the second leading cause of cancer death in the United States because screening rates are too low," said Mark Stenhouse, president of Cologuard. "These findings add to the growing body of real-world evidence that show Cologuard—with its high compliance and high sensitivity—can be part of the solution for patients at average risk for colorectal cancer."

Additionally, new research continues to support the strength of Cologuard in detecting right-sided polyps and cancers. In a real-world analysis of data from Mayo Clinic, researchers found (https://www.gastrojournal.org/article/S0016-5085(19)38402-1/fulltext) that among patients with a positive Cologuard result, the large majority went on to complete the recommended diagnostic colonoscopy. Of the patients who were found to have colorectal neoplasia at diagnostic colonoscopy, the proportion of right-sided lesions was higher in those with a history of prior colonoscopy compared to those who were new to screening, indicating that prior screening may have missed these right-sided lesions.

"These data underscore the value of Cologuard in improving colorectal cancer screening outcomes for average-risk adults," Stenhouse added.

Earlier detection impacts colorectal cancer outcomes. When colorectal cancer is detected in Stage I, about 90 percent of patients survive five years, and the removal of pre-cancerous lesions can further prevent the disease from progressing. Only about 11 percent of patients survive five years when the disease is detected in Stage IV.ⁱⁱⁱ

Since Cologuard received FDA approval in 2014, more than 160,000 healthcare providers have ordered Cologuard and more than 2.2 million Americans have been screened with Cologuard. Nearly half of Cologuard users surveyed by Exact Sciences Laboratories, after having been screened with Cologuard, self-reported that they had not previously been screened for colorectal cancer. Based on Cologuard's detection rate for early stage colorectal cancer and pre-cancerous polyps, Exact Sciences estimates the test may have helped detect as many as 10,000 early-stage cancers and approximately 70,000 pre-cancerous polyps.^iv

Additional abstracts by Exact Sciences' collaborators to be presented during DDW 2019 include: (https://www.gastrojournal.org/issue/S0016-5085(19)X6001-1)

Colonoscopy in Community Practice Following Fecal DNA Testing Among Patients in the New Hampshire Colonoscopy Registry
Multi-target Stool DNA Testing Enriches Detection of Colorectal Neoplasia by Colonoscopy but Yield is Influenced by Baseline Polyp Detection Rates
Multitarget Stool DNA Testing as Alternative for Colonoscopy-Based Surveillance: An Interim Analysis
Multi-Target Stool DNA Testing: Yield as a Function of Time Since Last Colonoscopy

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 of either sex, 50 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 advanced adenoma, 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. 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.

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.

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About Digestive Disease Week
Digestive Disease Week^® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18-21, 2019, at the San Diego Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

Media Contact:
Cara Connelly
Exact Sciences Corp.
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608-210-5735

Investor Contact:
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Exact Sciences Corp.
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ⁱ 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.

ⁱⁱ Compliance was defined as completion of the mt-sDNA test (positive or negative result) within 365 days of the order date

ⁱⁱⁱThe J Natl Cancer Inst 2009; 101:1412-1422.

iv 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

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