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Meridian Bioscience Premier C difficile GDH Assay wins FDA approval

Meridian Bioscience has received the US Food and Drug Administration (FDA) approval for its new Premier Clostridium difficile (C difficile) GDH Assay.

The assay detects a common antigen produced by toxigenic and non-toxigenic forms of C difficile bacteria.

Toxigenic forms of C difficile are frequently associated with hospital and community acquired diarrhea resulting from antibiotic therapy and in severe cases can cause a life-threatening inflammation of the colon.

Premier GDH is used by laboratories to screen patients with diarrhea for both forms of C Difficile.

To differentiate those patients at risk of disease with toxin-producing forms of C difficile, GDH-positive samples are re-tested with toxin-detecting tests such as Meridian’s Premier Toxins A&B or ImmunoCard Toxins A&B or with a molecular amplification assaysuch as Meridian’s illumigene C difficile test.

Meridian Bioscience CEO Jack Kraeutler said this third generation GDH assay is used for GDH identification and along with their toxin detection assays and their new illumigene molecular platform, affirms their position as the IVD Company that offers complete solutions for C difficile detection.