Thursday, April 24, 2014

GeneNews partner gets New York okay to market ColonSentry

February 21, 2012 by · Leave a Comment 

GeneNews (TSX:GEN) announced that Enzo Clinical Labs, a division of Enzo BioChem (NYSE:ENZ), has received approval from New York State’s Department of Health to market ColonSentry, a blood-based test to assess an individual’s current risk for colorectal cancer.

Enzo has exclusive rights to market the GeneNews ColonSentry test in the states of New York and New Jersey.

“The New York State review process is widely regarded to be amongst the most stringent in the clinical lab industry and provides important validation for the robustness of the ColonSentry test and underlying Sentinel Principle technology,” President Gailina J. Liew said in a statement.

“We are pleased that with this approval, the US population, representing the single largest established market for molecular diagnostic tests, will now have access to this clinically-actionable, innovative, and patient-friendly blood test,” she added.

Dr. Robert Burakoff, clinical chief of gastroenterology and director of the Center for Digestive Diseases and of the Crohn’s and Colitis Center at Brigham and Women’s Hospital, Harvard Medical School, said there is no question that the greatest barrier to reducing mortality arising from colorectal cancer is patient compliance with screening.

“The approval of blood tests to facilitate colorectal cancer screening is very much welcomed as we attempt to significantly increase compliance with screening colonoscopy at the appropriate age as there is still, unfortunately, a significant percentage of the US population that has not undergone screening for colorectal cancer, ” he added.

Ms. Liew concluded, “As a risk stratification test providing information about an individual’s current risk of having colorectal cancer, ColonSentry may facilitate a decision to undergo colonoscopy for those who would otherwise refuse the procedure.  Importantly, it can also help prioritize patients at greater current risk for colorectal cancer in healthcare systems with limited colonoscopy capacity. Widespread adoption of the test could lead to earlier detection of colorectal cancer, improved patient outcomes and reduced healthcare costs.”

Colorectal cancer is the second leading cause of cancer deaths in the US. Each year, there are approximately 154,000 colorectal cancer cases diagnosed and 52,000 deaths due to this disease. The American Cancer Society recommends that all men and women age 50 and older be regularly screened for colorectal cancer. However, only about half of this population is up-to-date on screening as many patients regard recommended tests such as colonoscopy and stool-based tests to be invasive or unpleasant, and consequently, refuse or delay testing.

According to the U.S. Centers for Disease Control and Prevention, or CDC, this low level of patient compliance with recommended colorectal cancer screening tests results in less than 40% of colorectal cancers being detected early. The CDC estimates that close to one-third of colorectal cancer-related deaths could be avoided if more people underwent regular screening. When colorectal cancer is found early and treated, the 5-year relative survival rate is 90%.

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