UA Clinical trial for detection of MRSA leads to FDA approval

The University of Arizona’s Infectious Disease Research Core (IDRC) was selected last spring by Cepheid (Sunnyvale, CA) as a clinical trial site for the company’s GeneXpert™ MRSA Assay. IDRC also served as the reference laboratory for the other clinical trial sites across the United States. The assay quickly detects one of the most threatening pathogens in healthcare worldwide – the bacteria methicillin-resistant Staphylococcus aureus (MRSA). MRSA is a common cause of skin infections and a variety of other severe infections. A form of MRSA has emerged as a severe public health pathogen, causing outbreaks of severe skin infections in hospitals, day care centers, sports teams, prisons, schools and families.

Cepheid received approval from the U.S. Food & Drug Administration (FDA) earlier this year to market the GeneXpert™ MRSA Assay. FDA approval was obtained quickly for reasons that include scientific method design, method performance, and quality assurance practices as designated by the federal Good Laboratory Practice (GLP) regulations. Screening programs for MRSA are an important part of a total infection control program and are one way to reduce the number of hospital infections. Rapid detection methods such as the GeneXpert™ MRSA Assay have the potential to impact screening strategies aimed at prevention of MRSA transmission.

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