BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Bloo... ( First Molecular Test to Simultaneous...)

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

Date:1/3/2008

First Molecular Test to Simultaneously Identify Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus from Positive Blood Cultures

SAN DIEGO, Jan. 2 /PRNewswire-FirstCall/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), announced today that it received clearance from the U.S. 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, M.D., Ph.D., Director of Clinical Microbiology, Wishard Memorial Hospital, Indianapolis, Indiana.

"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, 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 provides results within two hours, directly f
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BD Announces FDA 510(k) Clearance of Two-Hour Test to Identify Superbug in Patients with Positive Bloo...( First Molecular Test to Simultaneous...),Health