US nod for Meridian's Premier C diff assay
This article was originally published in Clinica
Executive Summary
Meridian Bioscience has received 510(k) clearance from the US FDA for a new Clostridium difficile immunoassay. The Premier C difficile GDH assay detects a common antigen produced by toxigenic and non-toxigenic forms of C difficile bacteria, glutamate dehydrogenase (GDH). Toxigenic forms are associated with hospital and community acquired diarrhoea resulting from antibiotic therapy and can cause life-threatening inflammation of the colon. Premier GDH is designed to be used to screen patients with diarrhoea for both forms of C difficile, to identify patients with toxin-producing forms of C difficile. Cincinnati, Ohio-based Meridian says that GDH-positive samples should be re-tested with toxin-detecting tests. Premier C difficile GDH has been available in Europe and the rest of world since October 2010. Meridian's illumigene C difficile stool sample test gained US 510(k) clearance last year (www.clinica.co.uk, 14 July 2010).
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