Healthcare Industry News: sDNA
News Release - July 11, 2007
EXACT Sciences' DNA Technology is Preferred Non-Invasive Method for Colorectal Cancer Screening Among PatientsNewly Published Study Confirms Earlier Findings
MARLBOROUGH, Mass.--(HSMN NewsFeed)--EXACT Sciences Corporation (NASDAQ: EXAS ) announced today the publication of a study which concluded that patients who are educated about, but inexperienced with, the various colorectal cancer (CRC) screening methods prefer stool-based DNA technology (sDNA) over other non-invasive methods. The study, entitled "Patient Preferences for Colorectal Cancer Screening: How Does Stool DNA Testing Fare?" appears in the July issue of The American Journal of Managed Care.
"Previously, we demonstrated in a large, multi-center study that patients who were experienced with colonoscopy, sDNA and fecal occult blood testing (FOBT) preferred sDNA over colonoscopy and over FOBT for their routine screening, and they did so by statistically significant margins(1)," said Paul C. Schroy III, MD, Professor of Medicine, Boston University School of Medicine and principal investigator of the study. "In the current study, we demonstrated that even inexperienced patients, when educated about each test, preferred sDNA over FOBT among the non-invasive options. More broadly, we also reaffirmed others' findings that patients value greatly the shared decision-making process between patient and physician, as advocated by the U.S. Preventative Services Task Force and the U.S. Multi-Society Task Force," continued Schroy. "It is reasonable, therefore, to expect that if physicians engaged patients in a shared decision-making process and spent the time to educate them about the pros and cons of the different screening tests, many patients would prefer a non-invasive approach, and particularly sDNA."
In the study, 263 subjects were educated about six CRC screening tests: colonoscopy, flexible sigmoidoscopy, FOBT, flexible sigmoidoscopy plus FOBT, double contrast barium enema and sDNA. The authors conclude that average risk patients who are inexperienced with screening prefer sDNA among non-invasive options and prefer colonoscopy, overall, due to its effectiveness. Importantly, the study also showed that most patients value a shared decision-making process with their physician when it came to test selection. Finally, the authors found that because colonoscopy and stool-based tests, particularly sDNA testing, are preferred over other options, it suggests that provider-patient decision making can be tailored to include fewer options.
Among the tests evaluated, patients preferred colonoscopy, sDNA and FOBT by a wide margin over all other options. In addition, while patients preferred colonoscopy overall (citing accuracy as the major factor), patients preferred sDNA over FOBT among non-invasive options by a statistically significant margin (p is less than 0.001). The authors state that the finding that sDNA is preferred over FOBT is particularly noteworthy since it not only corroborates previous patient preference studies (Schroy, 2005), but also suggests that even patients lacking prior experience with screening find sDNA more acceptable based on the perception of superior accuracy and a less demanding preparation.
"We are very encouraged by this additional evidence of patient preference for sDNA testing," said Don Hardison, President and CEO of EXACT Sciences. "We, and others in the medical community, continue to believe that to increase CRC screening and save more lives, we have to advance new screening tools that are both accurate and easy for the patient to perform. We also believe that sDNA meets these goals and, therefore, look forward to a positive decision by the American Cancer Society and the U.S. Multi-Society Task Force that will include sDNA in the updated CRC screening guidelines."
Colorectal cancer is the most deadly cancer among non-smoking men and women in the U.S., and the second most deadly cancer overall. Annually, there are nearly 154,000 CRC cases diagnosed and 52,000 deaths due to this disease(2). It is estimated that roughly one-third of CRC-related deaths could be saved if more people underwent regular screening. Early diagnosis results in a greater than 90 percent, five-year survival rate. The American Cancer Society (ACS) has set a goal of increasing to 75 percent the proportion of people over the age of 50 who have CRC screening consistent with the ACS guidelines by the year 2015.
About EXACT Sciences Corporation
EXACT Sciences Corporation uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. Colorectal cancer, which is the most deadly cancer among non-smokers, is generally curable if detected early. 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 from colorectal cancer remain high. EXACT Sciences believes its genomics-based technologies will help enable detection of colorectal cancer so that more people can be effectively treated. EXACT Sciences is based in Marlborough, Mass. PreGen-Plus(TM), the non-invasive colorectal cancer screening testing service based on EXACT's DNA technology, is offered by LabCorp® and has not been approved or cleared by the Food & Drug Administration.
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, among other things, the likelihood of the inclusion of stool-based DNA screening in any updated colorectal cancer screening guidelines and management's plans, objectives and strategies. 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 EXACT Science's technologies; the reproducibility of its research results in subsequent studies and in clinical practice; the inclusion of fecal DNA screening in colorectal cancer screening guidelines; sufficient investment in the sales and marketing of EXACT Sciences' technologies; the success of its strategic relationship with LabCorp; EXACT Sciences' ability to license certain technologies or obtain raw materials for its technologies; 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 the PreGen-Plus test; the ability of EXACT Sciences or LabCorp to lower the cost of the PreGen-Plus test 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 ability to protect EXACT Sciences' intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights; 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.
(1)Schroy PC and Heeren TC. Patient Perceptions of Stool-Based DNA Testing for Colorectal Cancer Screening. American Journal of Preventative Medicine 2005;28(2):208-14.
(2)American Cancer Society, Facts & Figures, 2007
Source: EXACT Sciences
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