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Prometheus Announces New Findings Regarding Patients at Risk for Celiac Disease at DDW

New Insights into the Prediction of IBD Using Serology Testing Also Presented

SAN DIEGO, June 2 /PRNewswire/ -- Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced new findings regarding a correlation between an important serologic marker used in the detection of Crohn's disease and particular genetic markers in patients at risk for celiac disease. In an oral presentation yesterday at Digestive Disease Week (DDW) in Chicago, Prometheus reported a statistically significant correlation between antibodies to the flagellin CBir1 and HLA haplotypes DQ2.5 and DQ8 in a study of 5,406 patients at risk for celiac disease who are EMA positive. Blood and serum samples were analyzed using PROMETHEUS(R) Celiac PLUS and PROMETHEUS(R) IBD Serology 7 diagnostic tests.

"Genetic tests to rule out celiac disease are now readily available. However, few genetically predisposed individuals actually develop the disease, despite gluten ingestion, for reasons that are not well understood," said Dr. Michelle Pietzak, a Pediatric Gastroenterologist in the Division of Gastroenterology at the University of Southern California Keck School of Medicine. "The results from this study show that an overly aggressive immune response to particular bacteria in the intestine, as in Crohn's disease, may contribute to the inflammation seen in patients with celiac disease."

New Insights into IBD Serology Testing

Results from two additional studies regarding the prediction of inflammatory bowel disease (IBD) using serology testing were also presented yesterday at DDW. The first examined the consistency of biomarkers in patients who received multiple PROMETHEUS IBD Serology 7 tests within a two-year period. The overall rate of repeat testing ordered was only 2.2%. The results showed high concordance between the original and repeat tests; median changes in biomarker serum concentrations ranged between 2.2 EU/mL and 4.3 EU/mL. These results are consistent with reports in the scientific literature suggesting biomarker stability over similar time periods. Further studies are required to evaluate the impact of therapy on biomarker stability over longer periods of time.

The clinical utility of PROMETHEUS IBD Serology 7 was further demonstrated in a separate, multi-center clinical study of an additional 1,574 patient samples, increasing the total development cohort of the test to a more heterogeneous 3,626 patient samples. Results with this large patient cohort further confirmed that using multiple markers combined with Prometheus' Smart Diagnostic Algorithm is more effective at differentiating IBD vs. non-IBD and Crohn's disease vs. ulcerative colitis than using traditional cutoff value analysis of the individual markers alone. PROMETHEUS IBD Serology 7 combines multiple serologic markers with a proprietary Smart Diagnostic Algorithm, which increases the sensitivity of the test by more than 25% when compared to single marker sensitivity values.

About Celiac

Celiac disease is an immune-mediated digestive disease that is triggered by the consumption of gluten and damages the small intestine, interfering with the absorption of nutrients from food. Gluten is a protein found in grains such as wheat, barley and rye. Symptoms of celiac disease will vary significantly from person to person and include, but are not limited to, diarrhea, anemia, abdominal pain, skin rash and weight loss. It is estimated that about 1% of people in the United States live with celiac disease and the disease is greatly undiagnosed. The number of diagnosed patients is expected to increase significantly over the next several years, driven by broad-based educational campaigns, National Institutes of Health research funding and widely-available genetic and blood tests for highly-specific antibodies.

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 a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and intends to apply these principles to oncology. 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.

SOURCE Prometheus Laboratories Inc.
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