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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