Data presented at the American College of Gastroenterology Scientific Meeting proves liquid phase assay superior to common solid phase ELISA assay
San Diego, October 22, 2012 – Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, will present five abstracts at the American College of Gastroenterology 2012 Scientific Meeting taking place this week in Las Vegas, NV. These data add to the compelling body of evidence that supports standardized use of liquid phase assays in helping to identify potential causes for loss of treatment response among inflammatory bowel disease (IBD) patients using infliximab (IFX).
PROMETHEUS Anser IFX is a proprietary, new generation monitoring test that helps guide patient management decisions – potentially saving IBD patients and their treating physicians valuable time and effort. This liquid phase assay, launched earlier this year, measures drug (infliximab) and drug antibody levels in the presence of drug (infliximab) at anytime in the course of therapy. Prometheus intends to use this platform for subsequent introductions of additional tests targeted to other biologic agents being used to treat a variety of autoimmune diseases.
In one abstract “Comparison of techniques for monitoring infliximab and antibodies to infliximab in Crohn’s disease patients with infliximab treatment failure” (Steenholdt et al), the PROMETHEUS Anser IFX diagnostic demonstrated superiority over ELISA, a commonly used solid phase assay for measuring both IFX and antibodies-to-infliximab (ATI) levels. The development of ATIs can shorten the duration of clinical response to IFX and decrease the likelihood of an IBD patient remaining in remission.
In the study, IFX and ATI levels were measured among 67 patients with infliximab treatment failure. PROMETHEUS Anser IFX proved more sensitive than ELISA in detecting absolute trough IFX concentrations (mean difference of 0.60 μg/ml). In addition, ATIs were detectable in only 6 (9%) of ELISA patients, as compared to 23 (35%) of the PROMETHEUS Anser IFX patients. Of the 17 samples for which ATI were detected by PROMETHEUS Anser IFX and missed by ELISA, 14 had detectable IFX levels that were likely missed due to interference from serum IFX, a common shortcoming of the solid phase ELISA assay and further support for the use of the new liquid test.
IBD, including Crohn’s disease and ulcerative colitis, is a chronic inflammatory condition of the intestinal tract. Symptoms of the disease may include diarrhea, abdominal pain, fever and rectal bleeding. Patients may require long-term medical care, including hospitalizations, surgeries and therapeutics. The condition can be difficult to diagnose and manage clinically while consuming a substantial amount of healthcare resources in terms of physician time, procedures and medications. The Crohn’s and Colitis Foundation of America estimates that approximately 1.4 million Americans suffer from IBD.
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), about 20% of the U.S. adult population has 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, many people suffer from IBS for years before being properly diagnosed and treated. The NIDDK also estimates that up to 70% 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 committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with more targeted solutions to optimize care for their patients. Prometheus became part of Nestlé Health Science in July 2011. Prometheus’ corporate offices are located in San Diego, California. For more information about Prometheus, please visit www.prometheuslabs.com.
About Nestlé Health Science
Nestlé Health Science, a fully-owned subsidiary of Nestlé S.A., has been operational since January 1, 2011 and has worldwide headquarters in Lutry, Switzerland. Nestlé Health Science offers nutritional solutions for people with specific dietary needs related to illnesses, disease states or the special challenges of different life stages. For more information about Nestlé Health Science, please visit www.nestlehealthscience.com.