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FDA Approves Cepheid Test for S. Aureas, MRSA

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Cepheid today announced it has received clearance from the US Food and Drug Administration to market its Xpert SA Nasal Complete.

The test is the only molecular diagnostic product designed for the detection and differentiation of Staphylococcus aureas and Methicillin-resistant Staphylococccus aureus colonization in under one hour, Cepheid said in a statement.

Available for shipment this month, Xpert SA Nasal Complete runs on Cepheid's GeneXpert system.

Up to 93 percent of hospital-acquired S. aureus infections are caused by a patient's own flora, making S. aureus nasal carriers about nine times more likely than non-carriers to develop surgical site infections, Cepheid said. Nasal carriage of the bacterium is also a major factor in self-infection in dialysis, ICU, and burn patients.

Hospitals spend about $9.5 billion annually trying to prevent and control hospital-associated S. aureaus infection and $20 billion on managing MRSA.

"A rapid test for both [S. aureus] and MRSA will have many applications for patients at risk for colonization," Samir Awad, associate professor of surgery and chief, section of critical care, at the Baylor College of Medicine, said. "Those applications include assisting physicians in targeting appropriate prophylactic therapy and decolonization to reduce the risk of post-surgical site infections."