Exact Sciences Presents New Data Reinforcing Performance of Cologuard®

Exact Sciences Presents New Data Reinforcing Performance of Cologuard®

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

PR Newswire

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.

Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

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.

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 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.

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.
[email protected] 
608-210-5735

Investor Contact:
Megan Jones
Exact Sciences Corp.
[email protected] 
608-535-8815

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

iii The 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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