Exact Sciences Advances Pipeline Capabilities with Mayo Clinic

Early data on pancreatic cancer detection presented at Digestive Disease Week® 2019

News provided by

May 20, 2019, 08:56 ET

SAN DIEGO, May 20, 2019 /PRNewswire/ -- Early research using blood-based methylated DNA markers, identified through the longstanding collaboration between Exact Sciences and Mayo Clinic, demonstrates a potential to achieve 92% sensitivity and 92% specificity for detecting the most common type of pancreatic cancer. Researchers presented the findings at Digestive Disease Week (DDW) 2019, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

"These pancreatic cancer data showcase the strength of our marker discovery collaboration with Mayo Clinic, a partnership that is fueling our product pipeline," said Kevin Conroy, chairman and CEO of Exact Sciences. "We aim to identify a minimally-invasive marker for a disease that often goes undetected until it progresses to an advanced stage, when fewer treatment options exist."

Pancreatic cancer is the third-leading cause of cancer-related deaths in the United States. According to the American Cancer Society, half of all pancreatic cancer patients are diagnosed in later stages when the five-year median survival rate is only 3%. No major guidelines recommend routine screening for average risk patients because the current detection options have not shown to lower a patient's risk of death.

Lead author and Mayo Clinic gastroenterologist Shounak Majumder, M.D. presented results from the 340-sample, case-control study. A panel of methylated DNA markers in plasma in combination with CA 19-9, achieved a cross-validated sensitivity of 79% in Stage 1, 82% in Stage 2, 94% in Stage 3 and 99% in Stage 4 pancreatic ductal adenocarcinoma (PDAC) with 92% specificity (81-100%). This combination was significantly better than CA 19-9 alone. As Majumder writes in the abstract, "CA 19-9 is unreliable for early detection and may be normal in advanced disease."

Statistical modeling was used to identify the best algorithm to predict disease status in this sample set. Subsequently, the panel was cross validated by randomly splitting the entire data set into training and testing sets. The fitted model from the training set was used to predict disease status in the test set over multiple iterations. This study used a small number of archival patient blood samples, which could lead to over-fitting to this particular sample set and cause subsequent sensitivity and specificity to decline in a larger, prospective population. A prospective validation study is currently underway at Mayo Clinic.

"Powered by more than a decade of work with Exact Sciences, Mayo Clinic researchers continue producing promising data, in this case on blood-based biomarkers for pancreatic cancer detection," said Paul Limburg, MD, MPH, AGAF, Exact Sciences chief medical officer and Mayo Clinic gastroenterologist.ⁱ "While further research must be completed, this serves as an early indicator of encouraging news in the fight against this deadly disease."

The Exact Sciences and Mayo Clinic collaboration focuses on identifying biomarkers for 15 of the deadliest cancers. A poster showing Mayo Clinic researchers work on esophageal cancer will also be presented at DDW.

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 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 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 CologuardTest.com Rx Only.

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]
614-302-5622

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

ⁱ Mayo Clinic and Dr. Limburg have a financial interest related to the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

SOURCE EXACT SCIENCES CORP