BD Announces FDA 510(K) Submission of Rapid Molecular Test to Identify Patients Carrying Staph Prior to Surgery

SAN DIEGO -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) announces that it has made a 510(k) submission to the Food and Drug Administration (FDA) for additional claims for the BD GeneOhmTM StaphSR assay. This will be the first assay for rapid and simultaneous identification of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from patients colonized in the nasal passage.

The BD GeneOhm StaphSR assay is a simple test that provides results within two hours directly from nasal swabs. The assay is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take two days to generate results.

Identifying patients colonized with MRSA or SA bacteria in advance of surgery helps ensure patients have an opportunity to be decolonized and receive the appropriate prophylactic antibiotics prior to surgery. This reduces the risk of a potentially deadly surgical site infection (SSI).

A recent study revealed that patients acquiring SSIs after coronary artery bypass graft (CABG) surgery had a one year mortality rate of 22 percent. This study also found that lengths of stay and costs increased by 20 days and $18,938, respectively, for this patient population.

Since the most frequent organism cultured in cardiac SSIs is Staphylococcus sp., and colonization is considered the major factor in wound contamination, the Society of Thoracic Surgeons issued guidelines recommending rapid PCR screening tests for Staphylococcus aureus colonization prior to surgery. For patients positive for Staphylococcus sp., decolonization with the antibiotic ointment mupirocin is recommended as a routine measure. In addition, a patient's colonization status is an important indicator in determining the appropriate prophylactic antibiotic to administer one hour prior to surgery.

Source: BD Diagnostics