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FDA Clears Meridian Bio's C. difficile Assay

NEW YORK (GenomeWeb News) – Meridian Bioscience announced on Tuesday that it its Clostridium difficile assay has been cleared by the US Food and Drug Administration.

The Cincinnati-based firm said that the ImmunoCard C. difficile GDH assay detects the C. difficile common antigen glutamate dehyrogenase, which is present in both toxigenic and non-toxigenic strains of the bacteria, and added that the test can be used to identify patients suspected to be infected with the bacteria. Those who test positive can then be confirmed for infection with a more specific molecular assay such as Meridian's illumigene C. difficile test, which was cleared by FDA in July 2010.

Used along with the molecular assay, the ImmunoCard C. difficile GDH assay provides laboratories with an "economical algorithmic option for C. difficile diagnostic testing," the company said.

"This new product, along with the Meridian illumigene C. difficile molecular assay, allows laboratories to identify C. difficile infected patients with a rapid screening test and molecular confirmation in less than two hours," the firm's CEO Jack Kraeutler said in a statement.