FDA OKs Meridian Bioscience’s Curian Analyzer and HpSA Assay

Meridian Bioscience Inc. a provider of immunoassay, molecular, and blood chemistry diagnostic testing solutions, has received FDA-clearance for Meridian’s new Curian and Curian HpSA assay. This analyzer and first assay play an important part in their initiative to maintain leadership in the gastrointestinal disease testing market.
 
Curian and Curian HpSA are designed to quickly detect Helicobacter pylori antigens in human stool using immunofluorescent technology. Curian HpSA is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment (i.e., confirmation of eradication). With a simple workflow and clean, comfortable sample handling; Curian HpSA provides healthcare systems a platform looking to standardize H. pylori testing from the industry’s leading experts in stool handling and testing.
 
The immunofluorescent technology of the Curian platform provides an objective, rapid H. pylori result with state-of-the-art clinical sensitivity, specificity, and a lower limit of detection than traditional rapid immunoassay testing. Combined with LIS connectivity, the Curian solution helps to eliminate subjectivity by reducing user variability related to interpreting and reporting visually based test results. “This is the first new platform internally developed at Meridian in several years,” said Dr. Larry Mertz, Senior Vice President of Research and Development / Clinical, “and the first of many new products we have in the pipeline continuing Meridian’s rich history of innovation.”
 
Meridian Bioscience offers an unparalleled H. pylori portfolio that accommodates any laboratory setting from low volume rapid testing to high volume automation, including the LIAISON Meridian H. pylori SA test. Jack Kenny, CEO, commented “Curian offers both competitive performance and reduced subjectivity with only a three-step workflow. This is yet another step Meridian is taking toward providing diagnostic platforms for healthcare systems looking to standardize testing, improve patient outcomes, and increase clinician satisfaction rates.”