Two Hour MRSA And Staph Blood Test Gets FDA 510 (k) Clearance

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Main Category: MRSA / Drug Resistance
Also Included In: Infectious Diseases / Bacteria / Viruses;  Blood / Hematology;  Regulatory Affairs / Drug Approvals
Article Date: 02 Jan 2008 - 13:00 PDT

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The FDA (Food and Drug Administration) have given clearance for the BD GeneOhm StaphSR assay. It is the first assay available to identify both Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) rapidly and at the same time from patients with positive blood cultures.

This will make it possible for doctors to use the right treatment at the right time for patients with bloodstream infections.

Thomas Davis, M.D., Ph.D., Director of Clinical Microbiology, Wishard Memorial Hospital, Indianapolis, Indiana, said "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,"

Vince Forlenza, Executive Vice President, BD, said "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. 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 gives a result within two hours directly from a positive blood culture. The makers say the assay is easy to perform and takes up less technologist time when compared to traditional microbiology algorithms, which can take up to two days to come back with results.

Studies have indicated that if doctors have crucial microbiology data earlier on it is possible to reduce mortality, length of hospital stay, as well as variable costs.

Currently, the BD GeneOhm™ MRSA assay quickly detects people who are colonized with MRSA and gives infection control professionals a better opportunity to break the chain of MRSA transmission.

http://www.bd.com.

Written by - Christian Nordqvist
Copyright: Medical News Today
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