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"This is an example of how genetic testing can impact healthcare decisionstoday, and we're excited to be offering a screening option that allows forearly and potentially life-saving detection of colon cancer," said RyanPhelan, founder and CEO of DNA Direct. "The ColoSure assay allows those whomight be anxious or fearful about invasive screening methods like colonoscopyto take steps to detect colorectal cancer in its earliest, most curablestages."
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At least 60 percent of Americans age 50 and older have never been screenedfor colorectal cancer, even though the American Cancer Society recommends alifelong screening program for those aged 50 or older, including a colonoscopyevery ten years. Each year, nearly 150,000 new cases are diagnosed, and up to50,000 people die of colorectal cancer. If caught early, the survival rate isclose to 95 percent -- but 50 percent of patients with colorectal cancer arediagnosed with advanced disease, which is less likely to be surgicallycurable.
ColoSure is the first clinical test available that looks for a DNA changein the vimentin gene, shown to be important to immunity and other importantcell processes in the body. If the vimentin gene is hyper-methylated, or"turned off," this could indicate colon cancer. A study published in theSeptember 2008 issue of the American Journal of Gastroenterology shows thatdetecting methylated vimentin DNA in feces provided both high sensitivity(77%) and high specificity (83%) for detecting early-stage, curable coloncancers.
"These data support the use of the ColoSure assay as a non-invasivescreening option," said Trish Brown, M.S., CGC, vice president of clinicalaffairs of DNA Direct. "This assay is among the most sensitive, non-invasivecolorectal cancer screening tools available to supplement screening betweenrecommended colonoscopy intervals."
DNA Direct's personalized, web-enabled report for recipients of theColoSure test includes an overview of test results, a lab report and letter tobring to their physician, and recommended next steps. Reports also reinforceawareness of the signs and symptoms of colorectal cancer, and include anoption to schedule a reminder for the patient's next screening. Finally, thereport includes a section on how ColoSure works, ways to change contributinglifestyle factors, a list of resources for patients and important facts aboutcolorectal cancer.
About ColoSure(TM)
The ColoSure(TM) assay assesses the presence of active colorectal cancerin average-risk individuals. The assay is performed, after a simple collectionprocess, on a complete bowel movement, and examines DNA in exfoliated coloncells for a change that can indicate the presence of cancer. The ColoSureassay can be used as a part of a comprehensive, ongoing colorectalcancer-screening program, and is complementary to both traditional and virtualcolonoscopies; current U.S. guidelines emphasize routine screening beginningat age 50. ColoSure has a sensitivity range (meaning that it detects thepresence of cancer) of 72-77 percent, and a specificity range (meaning that itdetects the absence of cancer) of 83-94 percent.
About DNA Direct
DNA Direct is a San Francisco-based, privately held company that providesconvenient, clinically valid personal genetic information and testing servicesto individuals, and provides genetic expertise to providers and labs. DNADirect creates customized, Web-enabled solutions that help integrate geneticinformation into healthcare decisions. For more information, visithttp://www.dnadirect.com.
SOURCE DNA Direct
