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FDA Approves Cepheid’s MRSA/SA Blood Culture Test

NEW YORK (GenomeWeb News) – Cepheid said today that it has received clearance from the US Food and Drug Administration to market its Xpert MRSA/SA Blood Culture test, which detects methicillin-resistant Staphylococcus aureus and Staphylococcus aureus in blood culture bottles showing gram-positive cocci.
 
The approval follows the FDA's clearance of a version of Cepheid's test that detects MRSA/SA in skin and soft tissue infections, which the company announced on Monday.
 
Cepheid said that the Xpert MRSA/SA Blood Culture test processes positive blood culture specimens and can determine if a patient's blood is infected with MRSA or SA within one hour.
 
Currently, Cepheid said, when patients exhibit signs of systemic infections, physicians must order culture-based tests that can take 24 to 48 hours to identify the specific organism causing the infection.
 
"Same day diagnostic results for blood culture bottles growing gram-positive cocci will empower physicians to begin targeted therapy in septic patients far sooner than current culture-based methods," said Ellen Jo Baron, director of clinical microbiology laboratories for Stanford University Hospital and director of medical affairs at Cepheid, in a statement.

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