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Back To Vidyya FDA Approves New Colorectal Cancer Screening Test

Test Is An Immunochemical Fecal Occult Blood Test (FOBT) That Detects Hidden (Occult) Blood That Originates In The Lower Intestine

Enterix Inc. announced today that its new colorectal cancer screening test, !nSure(TM), has received premarket clearance from the US Food and Drug Administration.

!nSure(TM) is an immunochemical fecal occult blood test (FOBT) that detects hidden (occult) blood that originates in the lower intestine, which might indicate a developing cancer. The new test was designed to address the compliance-limiting deficiencies associated with existing FOBTs, most of which are based on 30-year-old technology. These older tests have dietary and medicinal restrictions and patients must take fecal smears on three consecutive days.

Available in Australia since June, the new screening test already is being used by more than 900 primary care physicians to test men and women for colorectal cancer. Individuals who test positive are referred for colonoscopy, and the test has led to detection and removal of numerous cancers and pre-cancerous polyps.

Leading cancer experts believe that more frequent screening can play a major role in reducing the toll from colorectal cancer, the second leading cause of cancer-related death in the US With its easy-to-use test procedure, !nsure is expected to significantly improve patient participation.

"!nSure provides the opportunity to do something about this major health problem," said Graeme Young, MD, Director of Gastroenterology, Flinders University, Adelaide, Australia, and lead investigator of the !nSure clinical trials. "Our studies show that removing dietary restrictions and improving the sample collection method increases compliance." Young is a world-renowned expert on colorectal cancer detection and prevention, and will be the only non-US participant in the US Preventative Services Task Force meeting on colorectal cancer in Washington, DC, March 1-2, as part of National Colorectal Cancer Awareness Month.

"!nSure provides an excellent means for selection of asymptomatic individuals more likely to have colonic neoplasia and benefit from more invasive diagnostic evaluation by methods such as colonoscopy," added Young.

Clinical trials show that !nSure is highly sensitive and specific for the detection of colorectal cancer and pre-cancerous adenomas. In sensitivity trials, !nSure detected 87 percent of cancers and 47 percent of pre-cancerous polyps. In laboratory studies conducted by academic researchers, !nSure was shown to have ten-fold greater sensitivity than the leading competitor.

!nSure showed specificity of 98 percent in three separate clinical studies. Further, user preference studies have shown overwhelming preference for !nSure. When allowed to compare !nSure's brush method for sample collection vs. the fecal smear method, more than 80 percent of consumers preferred using the brush.

About Colorectal Cancer

Men and women 50 years and older are at risk for colorectal cancer, and the risk increases with age. In early stages, this cancer usually has no symptoms, develops slowly, and becomes evident by leaking tiny, invisible amounts of blood into the large intestine and feces. The blood can be detected by fecal occult blood tests (FOBTs). When found early, colorectal cancer is highly curable, with a 90 percent chance of survival after five years. If the disease invades the bowel wall and spreads to other organs, the survival rate is only 7 percent. When a person presents with symptoms, only 35 percent of the cancers are in the early stages of development.

FOBT screening has been scientifically proven to save lives. The efficacy of FOBTs in reducing colorectal cancer has been demonstrated in three major international studies. Results showed that colorectal cancer mortality decreased by up to 33 percent, and the incidence of the cancer decreased by up to 20 percent following regular FOBT screening. Despite the strength of data supporting FOBTs, currently available FOBTs are not widely used due to deficiencies perceived by both physicians and their patients.

Advantages of the new test include:

  • There are no dietary or medicinal restrictions

  • Patients do not handle their stool

  • The test is specific for lower intestinal bleeding

  • Only 2 days of sampling are required instead of three

  • Samples are mailed to a central laboratory for automated test development

  • Central development assures consistent quality and reliable delivery of annual testing

  • Results are forwarded to the physician and/or the patient


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Editor: Susan K. Boyer, RN
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