BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures

SAN DIEGO -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) announces today that it received clearance from the Food and Drug Administration (FDA) for the BD GeneOhm(TM) StaphSR assay. This new assay is the first test available to rapidly and simultaneously identify two deadly healthcare-associated infections (HAIs) -- Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) -- from patients with positive blood cultures. It will help enable physicians to implement the right treatment at the right time for patients with bloodstream infections, thereby transforming patient care and significantly reducing healthcare costs.

"The BD GeneOhm StaphSR assay provides a rapid, definitive identification of SA and MRSA from blood cultures. This allows for more appropriate isolation procedures and agent-specific antimicrobial therapy, resulting in reduced patient morbidity and mortality as well as an overall reduction in healthcare costs," said Thomas Davis, MD, PhD, director of clinical microbiology at Wishard Memorial Hospital in Indianapolis.

"The launch of the BD GeneOhm StaphSR assay in the United States further demonstrates BD's commitment to helping healthcare providers rapidly identify, prevent and control HAIs," said Vince Forlenza, executive vice president of BD. "It also illustrates our desire to provide customers with a complete menu of assays and tools to combat these potentially deadly infections."

The BD GeneOhm StaphSR assay is designed to provide results within two hours, directly from positive blood cultures. It is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take two days to generate results. Studies have shown that providing physicians with critical microbiology information earlier will result in decreased mortality, length of stay and variable costs.

Currently, the BD GeneOhm(TM) MRSA assay rapidly identifies patients who are colonized with MRSA and allows infection control professionals to break the chain of MRSA transmission. BD has recently submitted subsequent applications to the FDA for the BD GeneOhm StaphSR assay to add nasal swab and wound claims. BD is also developing rapid tests for the detection of two other organisms that cause severe HAIs. These tests will identify the vanA and vanB genes associated with vancomycin-resistant enterococci and the toxin gene associated with Clostridium difficile. These rapid assays will further complement the company's portfolio of HAI-related products.

Source: BD