Roche Snags 510(k) Clearance for Cobas Cdiff Test

May 26, 2015

Roche’s cobas Cdiff test for Clostridium difficile in stool specimens has FDA 510(k) clearance, the Swiss-based devicemaker announced Tuesday.

The diagnostic test works by targeting the toxin B gene in the bacterial strain and was developed to help prevent the spread of infection by allowing for early intervention. To this end, the test features high assay sensitivity, quick turnaround time and minimal pre-analytic steps, the company says.

In a U.S. multicenter clinical trial, the test demonstrated outstanding efficacy when compared to direct and enrichment toxigenic cultures, the devicemaker adds.

In addition to testing for C. difficile, the cobas 4800 platform can be used for Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus and both types of the herpes simplex virus. — Jason Scott