Switzerland-based Roche has received 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 test is said to target the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients.
Tricore Reference Lab and UNMHSC pathology department professor of Pathology Dr Steve Young said: "The cobas 4800 System has the capability to allow for mixed batch testing of the cobas Cdiff Test alongside testing for Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, and herpes simplex virus 1 and 2, all on one platform.
"We can run these assays together at least once in each shift rather than once a day, which can greatly improve laboratory efficiency, ultimately leading to better infection control and patient care."
According to the firm, the cobas Cdiff Test showed better performance compared to direct and enrichment toxigenic culture in a clinical trial program carried out at sites throughout the US.
To facilitate earlier intervention of patients suffering from C. difficile-associated disease, the test integrates high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps.
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."