SAN DIEGO, Oct. 7 Prometheus Laboratories Inc., a specialty pharmaceutical company, today announced findings from its development of PROMETHEUS(R) IBS Diagnostic, the first and only blood test for irritable bowel syndrome (IBS). The findings suggest measurable differences in the expression of particular biomarkers in blood samples between IBS and non-IBS patients. The identification of these biomarkers, combined with a proprietary algorithm, led to the development of PROMETHEUS IBS Diagnostic. These findings were presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Orlando, Florida.
"PROMETHEUS IBS Diagnostic is an exciting advancement in the field of functional gastrointestinal disease," said Dr. Anthony Lembo, M.D., a gastroenterologist in the Division of Gastroenterology at Beth Israel Deaconess Medial Center and an Assistant Professor of Medicine at Harvard Medical School. "This test complements current symptom-based diagnostic practices by identifying patients with biomarker patterns consistent or inconsistent with IBS."
Following an extensive analysis of approximately 600 to 700 pathways, each containing hundreds of potential IBS biomarkers, Prometheus scientists identified 16 biomarkers that showed sufficient altered expression. The expression levels of these 16 biomarkers were then measured in a sample cohort of more than 1,700 patients and analyzed to reveal optimal IBS prediction with a final set of 10 biomarkers, including some that enable Prometheus' proprietary protection. These biomarkers are associated with one or more of the following pathways related to digestion: motility, brain-gut axis, neuronal regulation and immune function.
"IBS can be very difficult to definitively diagnose and is therefore often left untreated," said Joseph M. Limber, President and Chief Executive Officer of Prometheus. "PROMETHEUS IBS Diagnostic is the first in a series of tests we are developing for this complex syndrome. It provides physicians a valuable tool to help clarify or validate other clinical findings. This test further strengthens our growing portfolio of proprietary, high-value diagnostics and complementary pharmaceutical products."
IBS can be challenging to diagnose because it is a functional disease that is not associated with any visible abnormality and symptoms often overlap with other gastrointestinal conditions, such as inflammatory bowel disease, celiac disease and chronic functional constipation/diarrhea. Symptom-based criteria have been established to make a positive diagnosis of IBS; however, in practice the diagnosis of IBS is typically made through a process of elimination by determining the patient does not have other gastrointestinal diseases with similar symptoms.
According to the National Institute of Diabetes and Digestive and Kidney Diseases, in 2007, almost 60 million, or 20%, of the U.S. population had symptoms of IBS, making it one of the most common disorders diagnosed by physicians. At least twice as many women as men are affected by IBS, a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation and diarrhea. Although it significantly impairs health-related quality of life, unfortunately, many people suffer from IBS for almost 3 years before being properly diagnosed and treated. It is believed that up to 75% of people suffering from IBS are not receiving medical care for their symptoms, due in part to the current difficulties of diagnosing IBS.
Prometheus Laboratories Inc. is a specialty pharmaceutical 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.
SOURCE Prometheus Laboratories Inc.