FDA clears BD Diagnostics BD MAX C. difficile assay

11 April 2013 (Last Updated April 11th, 2013 18:30)

The US Food and Drug Administration (FDA) has approved BD Diagnostics' BD MAX C. difficile assay.

The US Food and Drug Administration (FDA) has approved BD Diagnostics' BD MAX C. difficile assay.

Designed for use with a fully-automated BD MAX system, the CE-marked assay detects the toxin B gene (tcdB) in patients suspected of Clostridium difficile infection (CDI).

"CDIs are a growing threat in hospitals, nursing homes and other healthcare settings, according to the US Centers for Disease Control and Prevention."

CDIs are a growing threat in hospitals, nursing homes and other healthcare settings, according to the US Centers for Disease Control and Prevention.

Rapid, accurate identification of patients with CDI enables timely and appropriate therapy and infection control interventions to prevent the spread of the infection in healthcare institutions, according to the company.

BD Diagnostics diagnostic systems president Tom Polen said the Cdiff assay is a simple, easy-to-use, fully-automated method for detection of these dangerous bacteria.

"FDA clearance of the BD MAX Cdiff assay gives our customers the ability to balance productivity and cost as they perform laboratory testing for an expanding menu of infectious diseases," Polen said.

Other available assays include BD MAX MRSA for the detection of methicillin-resistant Staphylococcus aureus and BD MAX GBS for the detection of Group B Streptococcus.