Switzerland-based Roche has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its cobas Cdiff Test to detect Clostridium difficile (C. difficile) in stool specimens.
The cobas Cdiff Test is said to target the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients.
Roche Molecular Diagnostics head Paul Brown said: "With the addition of the cobas Cdiff Test to the cobas 4800 System menu, Roche is able to expand the tools available to assist clinicians in the management of healthcare associated infections.
"The cobas Cdiff Test requires less sample handling and provides laboratories with a simplified workflow, when compared to other molecular methods."
The cobas Cdiff Test showed better performance compared against direct and enrichment toxigenic culture in a clinical trial program carried at sites throughout the US, said Roche.
The test integrates high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps to facilitate earlier intervention of patients suffering from C. difficile-associated disease.
Roche noted that herpes simplex virus testing is not yet available for use on the cobas 4800 System in the US and its 510(k) submission is pending clearance.