Cepheid Molecular Diagnostic Test For MRSA And S. Aureus Categorized ‘Moderate Complexity’ By FDA

Cepheid (Nasdaq: CPHD) announced the U.S. Food & Drug Administration (FDA) categorized Cepheid’s Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in SSTIs.

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Filed under: MRSA / Drug Resistance on October 27th, 2008