First rapid on-demand molecular diagnostic test for MRSA and s. aureus cleared by FDA

The FDA approved a new test that can detect skin infections in less than one hour, HealthDay reports. Cepheid announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and soft tissue infections. MRSA is a bacterium that has become resistant to multiple antibiotics including penicillin and cephalosporins. Current culture-based lab testing methods require 48-72 hours to determine if a skin or soft tissue infection is caused by MRSA or SA. As a result, physicians and surgeons often prescribe broad-spectrum antimicrobial therapies while awaiting culture results.

Using specimens from SSTI swabs, the test is able to identify the presence of MRSA or SA in less than 60 minutes; current methods require growing cultures in a laboratory and can take two to three days. According to CDC data, skin infections drive nearly 12 million annual hospital visits, with treatment costs of roughly $9.5 billion.

Click here for the Cepheid release , 9/29; or HealthDay/Washington Post , 9/29 [registration required] or Arizona Daily Star , 9/27.

(SOURCE: Advisory Board Daily Briefing , http://advisory.com , September 30, 2008; Cepheid news release, http://cepheid.com , accessed October 5, 2008)