Drug Resistance
Cepheid Molecular Diagnostic Test for MRSA and S. aureus Categorized 'Moderate Complexity' by FDA
Published in Medical Letter on the CDC and FDA, November 2nd, 2008
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. Xpert MRSA/SA SSTI runs on Cepheid's GeneXpert(R) System, the leading platform for on-demand detection of Healthcare Acquired Infections (HAIs).
Cleared by the FDA for marketing last month, Xpert MRSA/SA SSTI is the first molecular SSTI diagnostic test to...
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