Cologuard a New Screening Test for Colorectal Cancer

In 2010, the National Cancer Institute estimates new cases of colon cancer 102,900 and 51,370 deaths (colon and rectal combined). 1 "Colorectal cancer is the second leading cancer killer in the United States and other developed countries." 10 The colon (large intestine or large bowl 2) is muscular tube-shaped organ (approximately five feet long 2), extending from the end of the small intestines to the rectum, then enters into the anus (End of the digestive track where feces leaves the body 3). The colon is the end section of the human gastrointestinal (GI) tract. The function of the colon: Digest (contains nearly 60 varieties of bacteria or microflora to aid digestion) and absorb nutrients from food, and eliminate feces. 4

Benign (polyps) or malignant tumors (cancer) arise within the wall of the large intestine. During a colonoscopy polyps are removed, preventing the likely hood to develop into cancer. Cancer in the colon and rectum (colorectal cancer) can metastasis (spread) to adjacent tissues and other parts or organs of the body including the liver and lung. "Once metastasis has occurred colorectal cancer, a complete cure of the cancer is unlikely." 5 Researchers are examining a new non-invasive test to detect pre-cancerous polyps and colon tumors, comparable more accurate than current blood test. 6

Dr. David Ahlquist of the Mayo Clinic in Rochester Minnesota developed a non-invasive test for colorectal cancer called Cologuard. 10 "Exact Sciences Corporation (Madison, Wisconsin 7) is a molecular diagnostic company focused on colorectal cancer." 8 Mayo Clinic licensed the test to Exact Sciences. 10 During the 2010 Special Conference for Colorectal Cancer: Biology to Therapy held by the American Association for Cancer Research in Philadelphia, PA. 12 - Preliminary study conducted by the Exact Sciences & the Mayo Clinic, confirmed Cologuard detected 64% of colorectal pre-cancer ("Pre-cancerous growths are described as polyps bigger than 1 centimeter." 11) and 85% of colon cancer, among a study of 1,000 frozen stool samples. "Exact Sciences' Cologuard test works by detecting abnormal DNA in cells that are shed into the stool from cancer or pre-cancerous lesions." 9 During a process called methylation, the Cologuard test peers for three genes that have been altered. 10 If Cologuard picks up abnormal DNA in stool a colonoscopy is recommended, confirm the diagnosis and remove the cancer or pre-cancerous polyps. 9

Cologuard test has advantageous compared to other colorectal cancer tests. According to Dr. Ahlquist the Cologuard test detects cancer throughout the entire area of the colon (other tests are not as reliable to examine the colon), and patients are not required to undergo any special preparation before taking the test. Also, the Cologuard test likely recommended once every three years, compared to fecal occult blood test (screening for colorectal cancer 13) usually done yearly. The future for the Cologuard test will be further improved according to Dr. Ahlquist: "We learned there are still some bugs and we can make the test even better." 6

Exact Sciences Corporation expects the cost for Cologuard approximately $300 to $400 per test (10) less than the estimate $700 cost for a colonoscopy. 6 Mayo Clinic estimates potential sales of Cologuard to reach $1 billion in the United States. 10 Potentially the new Cologuard test could test adults 50 and over recommended screening for colorectal cancer. Also, this non-invasive test may encourage forty percent of adults over the age of fifty, who have not been screened for colorectal cancer to undergo this exam.12

In 2011, clinical trials comparing Cologuard test with colonoscopy results will verify the credibility of the test. Dr. Ahlquist anticipates within two years Cologuard will be approved by the FDA and available for marketing. 6 Exact Science confirms, submit an application for Cologuard to federal regulators to market the test in 2012. 11

Dr. Floriano Marchetti, an assistant professor of clinical surgery in the division of colon and rectal surgery at University of Miami Sylvester Comprehensive Cancer said: "The dream is to eradicate colon cancer altogether and the most realistic approach is getting there is screening." 6

References:

1.) Colon and Rectal Cancer - http://www.cancer.gov/cancertopics/types/colon-and-rectal

2.) Digestive Disorders Health Center - http://www.webmd.com/digestive-disorders/picture-of-the-intestines

3.) Anus - http://en.wikipedia.org/wiki/Anus

4.) What is the function of your Colon and what does it do to keep you healthy? - http://www.colonhealth.net/colon_hydrotherapy/ct_funct.htm

5.) Colon Cancer (Colorectal Cancer) -

http://www.medicinenet.com/colon_cancer/article.htm

6.) Noninvasive Test for Colon Cancer Show Promise in Early Trial - http://www.businessweek.com/lifestyle/content/healthday/645057.html?campaign_id=rss_topStories

7.) Yahoo - Finance - Profile - http://finance.yahoo.com/q/pr?s=EXAS+Profile

8.) Exact Sciences' Upcoming Catalysts - http://www.rttnews.com/Content/TopStories.aspx?Id=1450176

9.) Exact Sciences Detects Early Colon Cancer - http://www.thestreet.com/story/10903220/1/exact-sciences-detects-early-colon-cancer.html?puc=_tscrss

10.) New colon cancer test works without colonscopy - http://news.yahoo.com/s/nm/20101028/hl_nm/us_cancer_colon_test_5

11.) Exact Sciences issues trial results for colorectal test - http://host.madison.com/wsj/business/article_f6536884-e2c8-11df-aefc-001cc4c03286.html

12.) Non-Invasive stool-based screening test detects 64% of colorectal pre-cancers - http://www.news-medical.net/news/20101029/Non-invasive-stool-based-screening-test-detects-6425-of-colorectal-pre-cancers.aspx

13.) Fecal Occult Blood Test - http://www.answers.com/topic/fecal-occult-blood