EXACT Sciences Corporation (NASDAQ: EXAS) today announced the publication in the American Journal of Gastroenterology the results of a multi-center study of EXACT’s Version 2 technology for stool-based DNA screening for colorectal cancer. The Company previously disclosed this study’s acceptance for publication and its top line performance for colorectal cancer detection. The study, conducted by Steven H. Itzkowitz, M.D, Professor of Medicine, Mount Sinai School of Medicine and his collaborators involved samples from 445 patients, which consisted of 82 colorectal cancers and 363 normal controls. The vast majority of cancers (83%) were detected regardless of tumor stage, tumor location, patient age, or the presence or absence of symptoms, with a specificity of 82%. In addition, 86% (6 of 7) precancerous adenomas with high grade dysplasia were also detected.
“Last month we saw results published on our newest detection technology from Johns Hopkins, demonstrating stool-based DNA detection rates for colorectal cancer above 90%,” commented Jeffrey R. Luber, President and Chief Executive Officer of EXACT Sciences. “This month we are pleased to see publication of the Version 2 study results, that similarly underscore the power and promise of non-invasive screening utilizing our technologies.”
“The ability to offer sensitive, non-invasive screening tests like sDNA is essential to reducing mortality among the tens of millions of people over age 50 for whom colorectal cancer screening is recommended by the American Cancer Society,” commented Steven Itzkowitz, M.D., Professor of Medicine and Principal Investigator of the study.
About Colorectal Cancer
Colorectal cancer is the most deadly cancer among non-smoking men and women in the United States, and the second most deadly cancer overall. The American Cancer Society estimates that nearly 150,000 cases will be diagnosed and 50,000 deaths are anticipated in 2008 due to this disease. Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, the rate of early detection of colorectal cancer remains low, and deaths remain high. It is estimated that roughly one-third of colorectal cancer-related deaths could be saved if more people underwent regular screening. Early diagnosis results in a greater than 90 percent, five-year survival rate.
EXACT Sciences Corporation
EXACT Sciences Corporation uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. EXACT maintains an exclusive license agreement with Laboratory Corporation of America® Holdings (LabCorp®) relating to the Company’s intellectual property. EXACT Sciences’ stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer (a group comprised of representatives from the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy), and the American College of Radiology. EXACT Sciences is based in Marlborough, Mass.
Certain statements made in this press release that are not based on historical information are express or implied forward-looking statements relating to, among other things, EXACT Sciences' expectations concerning the efficacy and potential patient acceptance of its colorectal cancer screening technologies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences' control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, the clinical performance and market acceptance of its technologies; the reproducibility of its research results in subsequent studies and in clinical practice; sufficient investment in the sales and marketing of EXACT Sciences' technologies; the success of its strategic relationship with LabCorp; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences' technologies; the ability to convince medical practitioners to order tests using EXACT Sciences' technologies; the ability to increase the performance of EXACT Sciences’ technologies; the ability of EXACT Sciences or LabCorp to lower the cost of stool-based DNA technologies through automating and simplifying key operational processes; the number of people who decide to be screened for colorectal cancer using EXACT Sciences' technologies; competition; the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer; and the ability to raise additional capital on acceptable terms. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences' public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC.
Jeffrey R. Luber, 508-683-1275
President & Chief Executive Officer