NEW YORK--Enzo Biochem, Inc. (NYSE:ENZ) today announced that it has entered into an agreement with GeneNews (TSX: GEN), of Toronto, Canada, for exclusive rights to market GeneNews’ ColonSentry™, a proprietary blood test for colorectal cancer, in the states of New York and New Jersey.
Enzo will undertake to validate and seek approval of the ColonSentry™ test pursuant to New York, New Jersey and CLIA [Clinical Laboratory Improvement Act] requirements, in addition to marketing, and securing third party reimbursement for the test. Terms were not disclosed. Enzo said that subject to regulatory and reimbursement approval, among others, it hopes to make the test available in the second half of 2010.
The test offers a novel, non-invasive option for determining an individual’s current risk for colorectal cancer and helps prioritize patients at greater risk for the disease.
“Enzo Labs’ objective is to become a world-class provider of both routine and esoteric clinical tests, including molecular diagnostics, in line with the changing dynamics in health care,” said Kevin Krenitsky, MD, President of Enzo Labs. “We are therefore pleased to join with GeneNews as its exclusive marketing partner in New York and New Jersey in making this product available to the medical communities we serve and their patients.”
“The greatest barrier to reducing mortality rates arising from colorectal cancer is patient compliance with screening,” said Dr. Bernard Levin, an internationally recognized expert in colorectal cancer screening and Chair of the GeneNews Colorectal Cancer Clinical Advisory Board. “As a blood-based test, ColonSentry™ can encourage individuals to undergo screening which could lead to earlier detection, thereby potentially reducing the suffering and death that can result from this highly treatable disease.”
“GeneNews is pleased to be working with Enzo, a leader in the diagnostic lab field,” said Dr. Heiner Dreismann, Lead Director and Interim CEO of GeneNews. “Enzo is our first US regional marketing partner and will provide an important segment of the eligible US population with access to our ColonSentry test.”
About Colorectal Cancer and Screening
In the U.S., colorectal cancer is the third leading cause of cancer deaths for men and women. Colorectal cancer has a very poor prognosis if it is diagnosed after the cancer has spread distantly outside the colon; however, if it is detected early it is usually curable. Additionally, detecting and removing pre-cancerous polyps may help prevent cancer from developing. Current screening tests are generally invasive, expensive, inconvenient or not readily available. As a result, the vast majority of individuals eligible for screening are not adequately screened. It is estimated that about 80 million people in the U.S. aged 50 or older would benefit from regular screening and that only approximately 45% of this group comply with current screening guidelines. Outside the U.S., screening compliance rates are much lower.
About Enzo
Enzo Biochem, Inc., is a growth-oriented integrated life sciences and biotechnology company focused on harnessing biological process to develop research tools, diagnostics and therapeutics, and serves as a provider of both routine and esoteric test services to the medical community. Since its founding in 1976, the Company’s strategic focus has been on the development of enabling technologies in the life sciences field. Enzo Life Sciences develops, produces and markets proprietary labeling and detection products for gene expression analysis, nucleic acid detection, protein biochemistry, and cellular analysis, among others. Its catalog of over 40,000 products serve the molecular biology, cellular biochemistry, drug discovery and pathology research markets worldwide. Enzo Clinical Labs division provides laboratory services for a growing roster of physicians in the New York Metropolitan area, as well as New Jersey and parts of Pennsylvania. Its tests include, in addition to routine tests, capabilities for detecting molecular infectious disease, molecular oncology, autoimmune disorders and genetics. Enzo Clinical Labs also provides clinical diagnostic services that allows Enzo to capitalize on its extensive advanced molecular and cytogenetic capabilities and the broader trends in predictive and personalized diagnostics. Enzo Therapeutics is a biopharmaceutical venture that has developed multiple novel approaches in the areas of gastrointestinal, infectious, ophthalmic and metabolic diseases. It has focused its efforts on developing treatment regimens for diseases and conditions for which current treatment options are ineffective, costly, and/or cause unwanted side effects. In the course of the company’s research and development activities, Enzo has developed a substantial portfolio of intellectual property assets, with over 240 issued patents worldwide and more than 200 pending patent applications.
About GeneNews
GeneNews is an emerging molecular diagnostics company focused on the application of functional genomics to enable early diagnosis and personalized health management based on disease-specific biomarkers. The Company has been granted a U.S. patent for its core platform technology, the Sentinel Principle®, which has the power to detect and stage virtually any disease or medical condition from a simple blood sample. GeneNews is currently applying the Sentinel Principle® in major areas with unmet clinical needs such as cancer, arthritis, cardiovascular disease and neurological disorders. GeneNews launched its first commercial product, ColonSentry™, a blood-based test to assess an individual’s risk for colorectal cancer, in Canada in 2008. For more information on GeneNews and ColonSentry™, visit www.genenews.com or www.colonsentry.com.
Except for historical information, the matters discussed in this news release may be considered "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this press release.
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