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Meridian Bioscience Receives FDA Clearance for Analyzer, H. Pylori Test

NEW YORK – Meridian Bioscience announced Monday its Curian analyzer and Curian HpSA assay received clearance from the US Food and Drug Administration. 

The analyzer and assay detect Helicobacter pylori antigens in stool samples using immunofluorescent technology and are intended to help clinicians diagnose the infection. They can also be used to confirm successful treatment of H. pylori, the company said.

The analyzer also reduces user variability related to interpreting visual test reports using algorithms to standardize results, and according to Larry Mertz, Meridian's senior vice president of R&D, the Curian is the first new internally developed platform from Meridian in several years.

The Cincinnati-based company has plans for additional assays for gastrointestinal conditions to run on the instrument now that the HpSA assay is FDA-approved.