Dec. 13, 2006 Mount Sinai School of Medicine and EXACT Sciences Corporation have announced 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. 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. The report concluded that consideration of new screening technologies, such as stool DNA testing, is warranted.
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