FDA News

BD Announces FDA 510 Submission Of Two Hour Test To Identify Superbug In Patients With Positive Blood Cultures

(April 25, 2007)--BD Diagnostics, a segment of BD announced that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, the first assay for the rapid and simultaneous identification of methicillin-sensitive Staphylococcus aureus (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA) from patients with positive blood cultures. This assay will enable physicians to implement the right treatment at the right time for patients with bloodstream infections, transforming patient care and significantly reducing healthcare costs.

The BD GeneOhm StaphSR assay is a fast, simple test that is performed directly from positive blood cultures. The assay requires less technologist time and provides results within two hours compared to over two days for traditional microbiology algorithms. Studies have shown that providing physicians with important microbiology information earlier results in decreased mortality, length of stay and variable costs.

The BD GeneOhm StaphSR assay promotes faster, better antibiotic selection to assist in preventing the emergence of vancomycin-resistant organisms, such as vancomycin-resistant Staphylococcus aureus (VRSA).

"The FDA submission of the BD GeneOhm StaphSR assay is another important step toward BD's commitment to help our customers rapidly identify, prevent, and control healthcare-associated infections (HAIs)," commented William Kozy, Executive Vice-President, BD. "Currently, the BD GeneOhm(TM) MRSA assay rapidly identifies patients that are colonized with MRSA and allows infection control professionals to break the chain of MRSA transmission earlier. Traditional culture techniques identify patients colonized with MRSA in two to three days, increasing the opportunity for transmission of this dangerous organism. We plan on making additional submissions to the FDA for wound and nasal swab claims with the BD GeneOhm StaphSR assay. We are also developing rapid tests for the detection of the vanA and vanB genes associated with vancomycin-resistant enterococci (VRE), as well as a rapid assay for the identification of Clostridium difficile (C. Diff.). VRE and C. Diff. are two other troublesome organisms causing severe HAIs."

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