FDA OK for Cepheid's Xpert MRSA tests
This article was originally published in Clinica
The US FDA has granted 510(k) clearance for two of Cepheid’s diagnostics for the detection of Staphylococcus aureus (SA) and methicillin-resistant S aureus (MRSA). The first was for its Xpert MRSA/SA SSTI (skin and soft tissue infections) test, which detects the bacteria in suspicious wounds or skin infections. The second is the Xpert MRSA/SA BC (blood culture) test, which detects the bacteria in Gram-positive blood culture bottles in patients with signs of life-threatening bloodstream infections. Both diagnostics produce results in under an hour, run on the GeneXpert System, and cost $75. Existing blood culture tests take up to 48 hours and patients receive broad-spectrum antibiotics in the interim which could lead to resistance, Sunnyvale, California-based Cepheid says.