BD Diagnostics, a segment of BD (Becton, Dickinson and Company), has announced that it has received FDA clearance to market the BD MAX Cdiff Assay in the United States. The assay is performed on the fully-automated BD MAXSystem and is designed to rapidly and accurately detect the toxin B gene (tcdB), which has been shown to be essential to cause disease in patients suspected of Clostridium difficile infection (CDI).
Rapid, accurate identification of patients with CDI enables timely and appropriate therapy and infection control interventions to prevent the spread of this infection in healthcare institutions. Use of molecular testing has been proven to reduce the number of healthcare facility-associated cases of CDI. The assay was CE-marked in March 2012, and it has demonstrated excellent performance in Europe.
The BD MAX Cdiff assay is the third FDA-cleared assay on the BD MAX System. 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. Both assays were categorized by FDA as CLIA Moderate Complexity tests. This latest milestone represents further confirmation of BD’s commitment to rapidly expand its menu, offering laboratories a broad range of molecular tests that meet both their current and future clinical needs. Read more about the BD Max Cdiff Assay.
