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

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE:BDX) , announced today that it has made a 510(k) submission to the U.S. 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.

About BD

BD, a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents, is dedicated to improving people's health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 27,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public

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