Prometheus Laboratories Inc. Presents New Clinical Insights Into Diagnosis of Crohn's Disease in Children from Analysis of PROMETHEUS(R) IBD Serology 7 Test Results

SAN DIEGO, Nov. 17 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced new findings regarding the correlation between serologic markers and the diagnostic predictions of children with Crohn's disease following an analysis of PROMETHEUS(R) IBD Serology 7 test results. Prometheus believes that PROMETHEUS IBD Serology 7 is the most comprehensive diagnostic test available to help physicians detect inflammatory bowel disease (IBD) and differentiate between Crohn's disease and ulcerative colitis.

A retrospective analysis of more than 145,000 test results showed distinct differences in serology patterns and, therefore, diagnostic predictions for pediatric patients versus adult patients. Levels of anti-CBir1, one of the markers in PROMETHEUS IBD Serology 7, were higher and predicted Crohn's disease more often in younger children than in adult patients with Crohn's disease. The elevated levels of anti-CBir1 in pediatric patients may be an important component used to predict Crohn's disease in children. These findings were presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and Children's Digestive Health and Nutrition Foundation (CDHNF) Clinical and Scientific Conference in San Diego on Saturday, November 15, 2008.

"Defining the natural history of childhood-onset Crohn's disease and further delineating the potential determinants of disease progression are important steps toward preventing clinical complications from this debilitating disease," said Marla C. Dubinsky, M.D., Director of the Pediatric Inflammatory Bowel Disease Center at Cedars-Sinai Medical Center in Los Angeles. "This large retrospective data analysis of PROMETHEUS IBD Serology 7 test results showing differences in serology patterns between children and adults may suggest a difference in immune pathways and, therefore, a unique bacterial etiology in children. This may have important implications for the treatment and prognosis in children, particularly those with very young onset of disease."

PROMETHEUS IBD Serology 7 includes the proprietary and patented markers anti-CBir1, anti-OmpC and DNAse-sensitive pANCA process that helps identify patients with IBD, as well as a proprietary algorithm to further improve predictive accuracy. In addition to providing a diagnostic prediction on every test, PROMETHEUS IBD Serology 7 also provides physicians with useful prognostic information to help determine some level of risk stratification for complications and course of disease.

"We believe these findings further reinforce the value and clinical utility of our diagnostic test in the diagnosis and prognosis of IBD while addressing a large unmet need in the pediatric gastroenterology community for serologic data," said Henry Pan, M.D., Ph.D., Chief Scientific and Medical Officer of Prometheus. "This analysis of our entire database of test results since the introduction of PROMETHEUS IBD Serology 7 to the market is another example of our ongoing commitment to the advancement of clinical research in the field of gastroenterology."

About IBD

IBD represents a group of chronic, progressive, recurring and debilitating inflammatory disorders of the gastrointestinal tract. Although IBD has no known cause, there is a presumed genetic component to susceptibility. It is estimated that Crohn's disease and ulcerative colitis, the two main types of IBD, together affect more than one million individuals in the U.S. The main difference between Crohn's disease and ulcerative colitis is the location and nature of the inflammation. Because the symptoms of Crohn's disease and ulcerative colitis are so similar, it is sometimes difficult to establish a definite diagnosis. However, differentiating between the two diseases is extremely important as treatment is often very different.

About Prometheus

Prometheus Laboratories Inc. is a specialty pharmaceutical and diagnostic company committed to developing and commercializing novel pharmaceutical and diagnostic products to help physicians individualize patient care. Prometheus is currently focused on the detection, diagnosis and treatment of gastrointestinal diseases and disorders in the United States. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary, high-value diagnostic testing services. By integrating pharmaceutical products and diagnostic testing services, Prometheus believes it can address the full continuum of care, thereby providing physicians with a comprehensive solution to treat chronic diseases. Prometheus' corporate offices are located in San Diego, California.

CONTACT: Pete De Spain, Director, Investor Relations & Corporate
Communications of Prometheus Laboratories Inc., +1-858-587-4117,
pdespain@prometheuslabs.com

Web site: http://www.prometheuslabs.com/

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