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Cepheid Receives FDA Clearance for S.aureus/MRSA Result in Less than an Hour

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Cepheid has received clearance from the FDA to market its Xpert™ MRSA/SA Skin and Soft Tissue Infection (SSTI) test, which runs on the GeneXpert® System, for the rapid detection of MRSA and Staphylococcus aureus in skin and soft tissue infections.

In less than one hour, Cepheid's Xpert MRSA/SA SSTI test processes specimens from suspected skin and soft tissue infection swabs to determine if a patient is infected with MRSA or SA, giving physicians and surgeons a powerful new tool to aid in selecting the most effective antibiotic therapy to improve patient management.

The GeneXpert® System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination.

It's the only system to combine on- board sample preparation with real-time PCR amplification and detection functions for fully integrated and automated nucleic acid analysis.

The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.

NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source : Cepheid View Company Information

Posted on September 29, 2008