ScheBo Biotech and Genova Diagnostics Expand Exclusivity Agreement for Non-Invasive Exocrine Pancreatic Test.Business Editors/Health/Medical Writers ASHEVILLE, N.C.--(BUSINESS WIRE)--Sept. 3, 2003 Future Collaboration to Focus On Developing Innovative Diagnostic Tests For Digestive Disorders ScheBo Biotech USA and Genova Diagnostics today announced they have expanded their licensing agreement, allowing Genova Diagnostics exclusive rights to offer the pancreatic elastase pancreatic elastase /pan·cre·at·ic elas·tase/ (e-las´tas) an endopeptidase catalyzing the cleavage of specific peptide bonds in protein digestion; it is activated in the duodenum by trypsin-induced cleavage of its inactive precursor 1 (PE1) assay. The PE1 assay is the only FDA-approved non-invasive diagnostic test of pancreatic elastase, a key digestive enzyme whose levels can be used to evaluate exocrine exocrine /exo·crine/ (ek´so-krin) 1. secreting externally via a duct. 2. denoting such a gland or its secretion. ex·o·crine adj. 1. pancreatic function. "With this agreement, we now have exclusive rights to the PE1 assay in the United States," says Frank Taylor, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Genova Diagnostics. "Our PE1 test will provide a reliable non-invasive assessment that the physician can use to help identify patients with pancreatic exocrine insufficiency pancreatic exocrine insufficiency, n low levels of pancreatic proteases and lipases in the small intestine resulting in improper digestion of carbohydrate, fiber, and protein foods, eventually leading to malabsorption. ." Assessing exocrine pancreatic function is important in the diagnosis and management of chronic pancreatitis chronic pancreatitis Chronic relapsing pancreatitis GI disease Recurrent pancreatitis linked to alcohol abuse or hemochromatosis, which may worsen with time. See Pancreatitis. , an inflammatory digestive disorder that affects thousands of Americans each year and results in over 1 million physician office visits annually. The disorder can be caused by alcoholism, abdominal trauma, surgery, heredity, or prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, use. The PE1 test can also identify pancreatic insufficiency caused by other health conditions, including cystic fibrosis, gallstones Gallstones Definition A gallstone is a solid crystal deposit that forms in the gallbladder, which is a pear-shaped organ that stores bile salts until they are needed to help digest fatty foods. , and diabetes mellitus. "Currently, PE1 appears to be the best non-invasive assessment of exocrine pancreatic function available," says Phillip P. Toskes, MD, Professor of Medicine Division of Gastroenterology, Hepatology, and Nutrition at the University of Florida University of Florida is the third-largest university in the United States, with 50,912 students (as of Fall 2006) and has the eighth-largest budget (nearly $1.9 billion per year). UF is home to 16 colleges and more than 150 research centers and institutes. College of Medicine. "Its sensitivity and specificity outperform other non-invasive pancreatic tests that have been evaluated." With a specificity and sensitivity greater than 90%, the PE1 test correlates strongly with the "gold standard" of pancreatic function assessment, the secretin-pancreozymin test. However, unlike the secretin-pancreozymin test, PE1 does not require intubation intubation /in·tu·ba·tion/ (in?too-ba´shun) the insertion of a tube into a body canal or hollow organ, as into the trachea. endotracheal intubation of the duodenum--a costly, time-consuming, and invasive procedure --and is thus better suited for routine use in clinical practice, especially with children. The PE1 technology and licensing agreement marks the start of a longstanding relationship between ScheBo Biotech USA and Genova Diagnostics. The two companies plan to collaborate in identifying additional diagnostic tools to address frequently encountered, yet difficult-to-diagnose gastrointestinal disorders. "Our goal is to develop precise non-invasive diagnostic tools that allow gastroenterologists to increase patient compliance and improve disease outcomes," Taylor said. The potential for future applications is considerable. According to the National Digestive Diseases Information Clearinghouse The National Digestive Diseases Information Clearinghouse (NDDIC) is an information dissemination service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The NIDDK is part of the National Institutes of Health, which is under the U.S. , digestive diseases affect about 60 to 70 million Americans and result in approximately 50 million physician office visits each year. Genova Diagnostics is a specialty clinical laboratory providing innovative tests and education for the diagnosis, prevention, and management of digestive diseases. Genova Diagnostics is committed to building a strong foundation of specialty diagnostic services through its active and dynamic partnerships with gastroenterologists. ScheBo Biotech USA, located in Marietta, GA, is a subsidiary of ScheBo Biotech AG of Giessen, Germany. ScheBo Biotech is a rapidly growing high-tech company founded in 1988 by biochemists and molecular biologists to develop, produce, and distribute new diagnostic tests. Continuous innovation, strong customer focus and a problem-solving philosophy have made ScheBo Biotech a leading global manufacturer of specialized diagnostics. |
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