Cepheid receives FDA clearance for updated Xpert MRSA/SA Blood Culture (BC) test

July 11, 2013

Cepheid has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert MRSA/SA Blood Culture (BC) test, which runs on the GeneXpert System, for the detection in about one hour of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically methicillin-susceptible) in blood culture bottles showing gram-positive cocci in clusters. Cepheid's updated Xpert MRSA/SA BC test processes positive blood culture specimens to determine if a patient's blood is infected with MRSA or SA.

Recent Centers for Disease Control and Prevention (CDC) data show that S. aureus (including MRSA) is the most common cause of central line-associated bloodstream infections, and together with coagulase-negative staphylococci (CoNS) represents almost 24% of all central line infections. Data on bloodstream infections from Mayo Clinic show that, taken together, S. aureus and CoNS represent almost 28% of significant positive blood cultures.

Typically, physicians will order a set of blood culture bottles drawn from patients presenting with symptoms of systemic infections. Positive cultures can appear in as little as 16 to 24 hours, but they then require further testing to identify the specific organism causing the infection. Although Gram stain results can be helpful for guiding empiric therapy, physicians have traditionally relied on slower culture methods, which often require an additional 24 to 48 hours.

Xpert MRSA/SA BC is available for immediate shipment. Learn more about Cepheid's comprehensive portfolio of healthcare-associated infection (HAI) tests.