BD Gets FDA Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Blood Cultures

 

January 28, 2008

BD Diagnostics said it received clearance from the FDA for the BD GeneOhm StaphSR assay, which the company says is the first test to rapidly and simultaneously identify two deadly healthcare-associated infections (HAIs) - Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA) - from patients with positive blood cultures.

BD says the test will 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,” said Thomas Davis, M.D., Ph.D., director of clinical microbiology, Wishard Memorial Hospital, Indianapolis, IN. “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.”

The BD GeneOhm StaphSR assay reportedly provides 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 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.

January 2008