Mount Sinai and EXACT Sciences announce study results on study stool DNA testing for colon cancer
88 percent sensitivity for colon cancer reported using non-invasive screening test
New York, NY and Marlborough, MA - (December 13, 2006) -- Mount Sinai School of Medicine and EXACT Sciences Corporation (NASDAQ: EXAS) announced today the publication of results from a prospective, multi-center study of stool DNA testing. The study found that the test demonstrated an 88% sensitivity for colorectal cancer, and with equal detection across all stages of cancer, regardless of the cancer’s location in the colon. The study was published online in the American Gastroenterological Association’s journal, Clinical Gastroenterology and Hepatology, and will appear in the January 2007 print issue. "This study confirms that stool-based DNA technologies can achieve high sensitivities for detecting colorectal cancer," stated Steven Itzkowitz, M.D., principal investigator and Professor and Associate Director of Gastroenterology at Mount Sinai School of Medicine. "For those individuals who are unwilling or unable to undergo colonoscopy, stool DNA testing offers a valuable and patient-friendly screening option. These results also underscore that as new markers and technologies are developed and validated, they can readily be incorporated into existing stool DNA tests to improve cancer detection and, ultimately, patient outcomes."
The published study, entitled "Improved Fecal DNA Test for Colorectal Cancer Screening," evaluated 162 patients, 40 individuals with cancer and 122 individuals with normal colonoscopies. An enhanced marker panel, using a refined DNA capture and stabilization process, detected 88% of cancers with a specificity of 82%.
"This publication is further validation that stool DNA technology offers a powerful tool for physicians and patients in detecting colorectal cancer," said Don Hardison, EXACT Sciences’ President and CEO. "Without new, non-invasive approaches such as stool DNA testing, it will be difficult to increase current colorectal screening and decrease mortality rates, a major goal for our company as well as a mandate of the American Cancer Society."
Colorectal cancer is the second leading cause of cancer deaths in the U.S. and more than half of the over 80 million people over the age of 50 have never been screened.1 A recent NCI study published in the American Cancer Society’s journal, Cancer, projected that, using traditional screening approaches, U.S. screening and mortality reduction goals cannot be achieved even under the most optimistic of scenarios.2 The report concluded that consideration of new screening technologies, such as stool DNA testing, is warranted.
About Mount Sinai Hospital
Mount Sinai Hospital is one of the nation’s oldest, largest and most-respected voluntary hospitals. Founded in 1852, Mount Sinai today is a 1,171-bed tertiary-care teaching facility that is internationally-acclaimed for excellence in clinical care.
About Mount Sinai School of Medicine
Located in Manhattan, Mount Sinai School of Medicine is internationally recognized for ground-breaking clinical and basic-science research, and innovative approaches to medical education. Through the Mount Sinai Graduate School of Biological Sciences, Mount Sinai trains biomedical researchers with an emphasis on the rapid translation of discoveries of basic research into new techniques for fighting disease. One indication of Mount Sinai’s leadership in scientific investigation is its receipt during fiscal year 2005 of $174.1 million in research support from NIH. Mount Sinai School of Medicine also is known for unique educational programs such as the Humanities in Medicine program, which creates opportunities for liberal arts students to pursue medical school, and instructional innovations like The Morchand Center, the nation's largest program teaching students and physicians with "standardized patients" to become not only highly skilled, but compassionate caregivers. Long dedicated to improving its community, the School extends its boundaries to work with East Harlem and surrounding communities to provide access to health care and educational programs to at risk populations.
About EXACT Sciences Corporation
EXACT Sciences Corporation uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. EXACTs newest technologies were recently described by TIME magazine (12/4/06) as "potentially lifesaving." 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.
1 Seeff LC, Manninen DL, Dong FB, Chattopadhyay SK, Nadel MR, Tangkas FK, Molinari NA. Is there endoscopic capacity to provide colorectal cancer screening to the unscreened population in the United States" Gastroenterology 2004;127(6):1841-4.
2 Vogelaar I, van Ballegooijen, M, Schrag D, Boer R, Winawer S, Habbema J, Zauber, A. How much can current interventions reduce colorectal cancer mortality in the U.S.": Mortality projections for scenarios of risk-factor modification, screening and treatment. Cancer 2006;107:1624-33.
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