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Celiac.com 06/19/2009 - Specialty pharmaceutical and diagnostic company, Prometheus Laboratories Inc., announced results from two recent studies concerning the use of serologic testing to predict inflammatory bowel disease (IBD).
The first study assessed the consistency of biomarkers in patients who received multiple Prometheus IBD Serology 7 tests within a two-year period. Overall levels for repeat testing orders were just 2.2%. Original and repeat tests showed a high degree of agreement. Average variation in biomarker serum concentrations ran between 2.2 EU/mL and 4.3 EU/mL.
Results agreed with prior studies suggesting biomarker stability over similar time periods. Further studies are needed to gauge the impact of therapy on biomarker stability over the long term.
A second, multi-center clinical study of 1,574 subject samples brought the total development cohort of the test to a more heterogeneous 3,626 patient samples.
Results with this large patient cohort further showed that combining multiple markers with Prometheus' Smart Diagnostic Algorithm permits clinicians to better distinguish IBD vs. non-IBD and Crohn's disease vs. ulcerative colitis, compared to standard cutoff value analysis of the individual markers alone.
Prometheus IBD Serology 7 combines multiple serologic markers with a proprietary Smart Diagnostic Algorithm, increasing test sensitivity by more than 25% over single marker sensitivity values.
Medical News Today