MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS) today announced that a new peer-reviewed study of Cologuard®, a multi-target stool DNA test (MT-sDNA), confirms its performance across all stages of colorectal cancer and showcases how the at-home test could improve access to screening. In the study of 661 average risk Alaska Native people, Cologuard detected 100% (10/10) of colorectal cancers and 52% (24/46) of significant premalignant lesions (adenomas >1 cm) in people between the ages of 40-85. The detection rate of Cologuard increased to 80% for the largest pre-cancers (>3 cm), which are most likely to progress to cancer. The study, “Stool DNA Testing for Screening Detection of Colorectal Neoplasia in Alaska Native People” is published in today’s Mayo Clinic Proceedings.
The Alaska Native people have among the world’s highest rates of colorectal cancer, more than twice the rate of U.S. Caucasians. Colorectal cancer is also the most commonly diagnosed cancer among this population. Conventional invasive screening approaches, such as colonoscopy, present access challenges for people in remote Alaskan villages. The colorectal cancer screening rate for some Alaska Native people is as low as 23%, far below the national screening rate of 58%.
“This research is further evidence that Cologuard is highly sensitive in detecting both early stage colorectal cancer and the most advanced precancerous polyps that are most likely to develop into cancer," said David Ahlquist, M.D., a Mayo Clinic gastroenterologist, study investigator and co-inventor of the test. “A sensitive screening test like Cologuard that is delivered to a patient’s home provides an opportunity to reverse that trend not only in Alaska but also in other rural and remote areas where patients have limited access to screening.”
As part of the study, which mirrored a previously published (New Engl J Med April 2014) 10,000 patient prospective study of Cologuard, participants underwent both Cologuard and fecal immunochemical testing (FIT) prior to a pre-scheduled screening or surveillance colonoscopy. The Alaska Native study results improved upon the previously published results, showing a higher rate of sensitivity for colorectal cancer and pre-cancer and an increased specificity. FIT detected 80% (8/10) of colorectal cancers and only 30% of significant premalignant lesions (adenomas >1 cm). Cologuard achieved a specificity of 93% and FIT achieved a specificity of 96%.
“This study of Alaska Native people confirms the power of Cologuard and reaffirms its importance in our effort to increase America’s stagnating colon cancer screening rates,” said Kevin Conroy, chairman and CEO of Exact Sciences. “Not only did Cologuard’s sensitivity remain high across all cancer stages and pre-cancers, but its false positive rate decreased. Cologuard’s performance highlights its role as a screening option.”
Mayo Clinic and Dr. Ahlquist have a financial interest in the technology described in this news release.
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 April 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.
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. 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. 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 noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.
Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and 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,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this news release may address the following subjects among others: statements regarding the sufficiency of our capital resources, our ability to secure favorable reimbursement rates from Medicare and other third-party payors, timing of our launch of a commercial product, our estimates of the available market size and our potential penetration, expected research and development expenses, expected general and administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those 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 urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.