• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

New Potential Application for Stool DNA Testing Demonstrated in Research Study; EXACT Sciences' Technology Evaluated for Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease

Posted on: Tuesday, 23 May 2006, 16:57 CDT

EXACT Sciences Corporation (NASDAQ: EXAS) announced today results of a research study regarding a potential new application of its stool DNA testing technologies at the annual Digestive Disease Week (DDW) conference. The data were presented during the "Biomarkers and GI Cancers Research Forum" at the Los Angeles Convention Center.

The study, described in a presentation entitled "Expression of Multiple Simultaneous Biomarkers in Tissues of Patients with Colitis-Associated Neoplasia," describes data from a tissue study evaluating the sensitivity of a prototype marker panel targeting alterations in ulcerative colitis carcinogenesis.

Ulcerative colitis and Crohn's colitis are serious gastrointestinal conditions, collectively know as "Inflammatory Bowel Disease," or IBD. According to the National Institutes of Health (NIH), IBD affects as many as one million people in the U.S., and individuals with longstanding IBD are at increased risk for developing colorectal cancer. Despite this increased risk, the heightened inflammation associated with IBD makes it more difficult to detect colorectal neoplasia with colonoscopy than in those without IBD. Therefore, approaches that are complementary to colonoscopy are being actively explored. We believe that stool DNA holds great promise in this regard.

Because inflammation often affects wide areas of the colon in IBD patients, and since cancerous lesions arise from these areas, there is the potential for more cells with mutated DNA to be shed into the stool than in an average individual. An approach using stool DNA testing, therefore, could potentially increase colorectal cancer detection rates in patients with IBD.

Since many of the genetic mutations associated with colorectal carcinogenesis are also associated with ulcerative colitis, researchers set out in this study to determine whether colitis-associated neoplasia (CAN) could be detected by applying a prototype panel of molecular markers to tissue samples taken from affected individuals. In their preliminary results, researchers found that CANs could be detected in tissue using a prototype marker set. Because the molecular progression of CRC in IBD patients differs markedly from that in average risk individuals, a refined configuration of markers needs to be evaluated. If follow-up studies confirm this, stool DNA testing may be helpful as a partner to colonoscopy in detecting colorectal cancer in the large population of IBD sufferers.

"Using this prototype molecular marker panel, we detected 44% of colitis-associated neoplasias," commented Dr. Steven Itzkowitz, Professor and Associate Chief, Division of Gastroenterology, Mount Sinai School of Medicine. "Given the often multi-focal nature of neoplasia in colitis, it is possible that stool diagnostics might perform better than analyzing tissue. We are therefore encouraged to investigate the existing markers, and an even more refined marker panel, targeting additional alterations known to be involved in colitis-associated neoplasia. This could be very important, since this group is at higher risk for developing cancer, and should be monitored very closely. Stool DNA testing may play a role that is complementary to colonoscopy in monitoring these patients."

"While EXACT Sciences has focused its research efforts primarily on colorectal cancer screening in the general population, we have also explored the potential of broadening our technologies' application to other gastrointestinal conditions that affect a significant number of U.S. citizens today," commented Don Hardison, President and CEO of EXACT Sciences. "These research findings are very exciting to us, as they offer the potential of broadening the application of stool DNA testing to include IBD-associated neoplasia. We and others believe that, over time, stool could potentially serve as the sample source for the detection of a broad array of cancers in the gastrointestinal tract and elsewhere," concluded Hardison.

About EXACT Sciences Corporation

EXACT Sciences Corporation uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. Certain of its technologies have been licensed to Laboratory Corporation of America Holdings (LabCorp) for a stool-based DNA screening assay for colorectal cancer in the average-risk population. 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. Founded in 1995, EXACT Sciences is based in Marlborough, Mass. PreGen-Plus(TM) 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 performance and market acceptance of its technologies, the likelihood of publication and acceptance of its scientific data, and the research and development strategies of Laboratory Corporation of America Holdings (LabCorp). 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; the success of its strategic relationship with LabCorp; EXACT Sciences' and LabCorp's 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 stool-based DNA screening test; the ability of EXACT Sciences or LabCorp to lower costs through automating and simplifying key operational processes; the inclusion of stool-based DNA screening in cancer screening guidelines; sufficient investment in the sales and marketing of stool-based DNA screening; the number of people who decide to be screened for colorectal cancer using stool-based DNA screening; competition; the ability to comply with federal and state statutes and regulations relating to EXACT Sciences' products and services, including FDA requirements, the U.S. Department of Transportation and the Clinical Laboratory Improvement Amendments; 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.

Source: Business Wire

More News in this Category