Stool DNA Screening Technology to be Featured at ACG 2015

Three posters from Exact Sciences highlight new data suggesting that availability of sDNA technology may improve colorectal cancer screening.

HONOLULU(BUSINESS WIRE) Exact Sciences Corp. (NASDAQ: EXAS) today announced that data supporting its stool DNA (sDNA) screening platform for colorectal cancer will be presented in three posters at the American College of Gastroenterology's Annual Scientific Meeting (ACG 2015), taking place October 16-21 in Honolulu.

It is estimated that colorectal cancer will be responsible for more than 50,000 deaths in the United States this year. The American Cancer Society recommends that Americans age 50 and older get screened for the disease. Unfortunately, according to the Centers for Disease Control, 42 percent are not current on their screening. One of the key barriers to screening compliance is that while colonoscopy is highly effective, many patients are unable or unwilling to undergo the procedure. Approved last year by the FDA, Exact Sciences' Cologuard® is a noninvasive, patient-friendly, at-home screening test that uses advanced sDNA technology to analyze a patient-provided stool sample for the presence of altered DNA from abnormal cancerous or precancerous cells known to be associated with colon cancer and blood.

  • The first poster, Colorectal Cancer Screening with Multi-target stool DNA-based Testing Previous Screening History of the Initial Patient Cohort, shows that a clinically significant proportion of initial Cologuard users, 42 percent, age 50-74, the primary target age for screening , reported no previous colorectal cancer screening, while 36 percent of users over all were similarly unscreened previously. These data suggest that the availability of Cologuard as a screening option may help increase the number of patients who get screened.
  • In a second poster, Multi-target stool DNA based Colorectal Screening Modeling the Impact of Inter-test Interval on Clinical Effectiveness, researchers looked at the decrease in colorectal cancer incidence and colorectal cancer death with sDNA screening compared to colonoscopy at various intervals. The study found that screening with Cologuard at three-year intervals could reduce colorectal cancer death by 67 percent.
  • In a third poster, Preferences for Colorectal Screening Tests Among a Previously Unscreened Population, a newly completed patient preference study, corroborating the finding of the two previously published preference studies, finds that screen-naïve patients, who intend to be screened within the next year, prefer colonoscopy (40 percent) and multi-target sDNA (35 percent) significantly more often than FOBT or FIT (9-10 percent) or flexile sigmoidoscopy (4 percent). There was no significant preference difference between colonoscopy and multi-target sDNA, but the difference between colonoscopy and multi-target sDNA compared to the other three tests was significant.

"The strong clinical data presented today at ACG clearly demonstrate the positive impact of sDNA technology on improved patient compliance with critical and life-saving colon cancer screening," said Kevin Conroy, Chairman and CEO of Exact Sciences. "Exact Sciences is committed to continuing to build on the growing body of evidence validating Cologuard as an important new tool for the early detection of colorectal cancer and we look forward to sharing these developments with the clinical community."

All posters will be on display on Monday, October 19 between 10:00 a.m. and 3:30 p.m. in the Exhibition Hall and authors will be available between 11:40 a.m. and 12:40 p.m. to provide commentary and insight on the data and implications.

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 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 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.


Exact Sciences Corp.
Cara Tucker, 614-302-5622
Jayme Maniatis or Jane Hauser, 781-684-0770

Source: Exact Sciences Corp.

Topics: Exact Sciences News

Subscribe To The Blog