Patent Issued Related to Prometheus Laboratories Inc. Proprietary Test CBir1 Antigen Test Included in Diagnostic for Inflammatory Bowel Disease

SAN DIEGO, Aug. 21 /PRNewswire/ -- Prometheus Laboratories Inc. announced the issuance of U.S. Patent No. 7,361,733, “Compositions and Methods for the Therapy and Diagnosis of Inflammatory Bowel Disease” which protects a flagellin peptide useful in the detection of antibodies to the flagellin CBir1, or anti-CBir1, for determining the presence of inflammatory bowel disease (IBD). This proprietary technology is used in the Company’s PROMETHEUS(R) IBD Serology 7 test and its recently launched PROMETHEUS(R) IBS Diagnostic test. Prometheus has exclusive rights to this technology under an agreement with Corixa Corporation.

The patent provides a means of detecting the presence and levels of CBir1 antibodies in a patient sample. Approximately 50% of patients with Crohn’s disease have a positive response to anti-CBir1. The presence of anti-CBir1 identifies a subset of patients with Crohn’s disease who were not previously detected by other serologic markers. Before the introduction of anti-CBir1, patients who were pANCA positive may have been diagnosed as having ulcerative colitis. However, anti-CBir1 helps physicians to further characterize pANCA-positive patients and distinguish between ulcerative colitis and ulcerative colitis-like Crohn’s disease. In addition, anti-CBir1 may be associated with more complicated Crohn’s disease and with phenotypes involving small bowel disease, such as fibrostenosis and internal perforating disease.(1)

Prometheus is a leader in providing therapeutics and diagnostics for gastrointestinal diseases and has been at the forefront in offering unique, proprietary testing of blood-based biomarkers with high clinical value. PROMETHEUS IBS Diagnostic is the first blood-based biomarker test to help physicians diagnose irritable bowel syndrome (IBS). PROMETHEUS IBD Serology 7 is the most comprehensive IBD diagnostic testing service available to help physicians detect IBD and differentiate between Crohn’s disease and ulcerative colitis.

About IBD and IBS

Crohn’s disease and ulcerative colitis are two main types of IBD. 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 may be very different. IBS is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation and diarrhea. IBS causes substantial discomfort and distress.

About Prometheus

Prometheus Laboratories Inc. is a specialty pharmaceutical company committed to developing new ways to help physicians individualize patient care. Prometheus focuses on the treatment, diagnosis and detection of gastrointestinal, autoimmune and inflammatory diseases and disorders. Prometheus’ strategy includes the marketing and delivery of pharmaceutical products complemented by its proprietary, high-value diagnostic testing services. By integrating these therapeutic and diagnostic services, Prometheus addresses 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.

Additional information about Prometheus can be found at http://www.prometheuslabs.com.

1 Targan SR, Landers CJ, Yang H, et al. Antibodies to CBir1 flagellin define a unique response that is associated independently with complicated Crohn’s disease. Gastroenterology. 2002;123:689-699.

CONTACT: Beth Kriegel, Vice President, Finance, +1-858-410-2516, or Pete
De Spain, Director, Investor Relations & Corporate Communications,
+1-858-587-4117, both of Prometheus Laboratories Inc.

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

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