SAN FRANCISCO, Oct. 1 /PRNewswire/ -- DNA Direct, Inc. today announced that the company will offer ColoSure(TM), a state of the art, safe, simple, and convenient test to screen for colon cancer -- the second leading cause of cancer-related deaths in the United States. ColoSure tests a single stool sample for a DNA marker associated with colorectal cancer, and may be ordered through DNA Direct's website at http://www.dnadirect.com.
"This is an example of how genetic testing can impact healthcare decisions today, and we're excited to be offering a screening option that allows for early and potentially life-saving detection of colon cancer," said Ryan Phelan, founder and CEO of DNA Direct. "The ColoSure assay allows those who might be anxious or fearful about invasive screening methods like colonoscopy to take steps to detect colorectal cancer in its earliest, most curable stages."
At least 60 percent of Americans age 50 and older have never been screened for colorectal cancer, even though the American Cancer Society recommends a lifelong screening program for those aged 50 or older, including a colonoscopy every ten years. Each year, nearly 150,000 new cases are diagnosed, and up to 50,000 people die of colorectal cancer. If caught early, the survival rate is close to 95 percent -- but 50 percent of patients with colorectal cancer are diagnosed with advanced disease, which is less likely to be surgically curable.
ColoSure is the first clinical test available that looks for a DNA change in the vimentin gene, shown to be important to immunity and other important cell processes in the body. If the vimentin gene is hyper-methylated, or "turned off," this could indicate colon cancer. A study published in the September 2008 issue of the American Journal of Gastroenterology shows that detecting methylated vimentin DNA in feces provided both high sensitivity (77%) and high specificity (83%) for detecting early-stage, curable colon cancers.
"These data support the use of the ColoSure assay as a non-invasive screening option," said Trish Brown, M.S., CGC, vice president of clinical affairs of DNA Direct. "This assay is among the most sensitive, non-invasive colorectal cancer screening tools available to supplement screening between recommended colonoscopy intervals."
DNA Direct's personalized, web-enabled report for recipients of the ColoSure test includes an overview of test results, a lab report and letter to bring to their physician, and recommended next steps. Reports also reinforce awareness of the signs and symptoms of colorectal cancer, and include an option to schedule a reminder for the patient's next screening. Finally, the report includes a section on how ColoSure works, ways to change contributing lifestyle factors, a list of resources for patients and important facts about colorectal cancer.
The ColoSure(TM) assay assesses the presence of active colorectal cancer in average-risk individuals. The assay is performed, after a simple collection process, on a complete bowel movement, and examines DNA in exfoliated colon cells for a change that can indicate the presence of cancer. The ColoSure assay can be used as a part of a comprehensive, ongoing colorectal cancer-screening program, and is complementary to both traditional and virtual colonoscopies; current U.S. guidelines emphasize routine screening beginning at age 50. ColoSure has a sensitivity range (meaning that it detects the presence of cancer) of 72-77 percent, and a specificity range (meaning that it detects the absence of cancer) of 83-94 percent.
About DNA Direct
DNA Direct is a San Francisco-based, privately held company that provides convenient, clinically valid personal genetic information and testing services to individuals, and provides genetic expertise to providers and labs. DNA Direct creates customized, Web-enabled solutions that help integrate genetic information into healthcare decisions. For more information, visit http://www.dnadirect.com.
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