FDA Approves Roche's MRSA Detection Test for Use in the U.S.

Roche Molecular Systems, Inc. announces that the Food & Drug Administration (FDA) has cleared its new LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the U.S. The LightCycler® MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with bacterial MRSA, and it is designed to aid in the prevention and control of MRSA infections in healthcare settings. Roche's new real-time polymerase chain reaction (PCR) test delivers rapid results (within two hours) and appears to have better sensitivity compared to direct culture-based methods.

High rates of infection, mortality, and high costs of treatment due to healthcare-associated infections (HAIs) caused by MRSA are a critical issue for healthcare facilities worldwide. In addition, community-associated MRSA (CA-MRSA) infection has spread in the U.S., feeding the pipeline of infection in hospitals, and underscoring the need for comprehensive infection control programs along with more rapid and reliable MRSA screening methods. In response to this public health issue, an increasing number of states have passed legislation requiring mandatory reporting and/or screening for HAI's.

"The introduction of this new advanced test will expand the options healthcare facilities have for MRSA screening using molecular diagnostic methods," said Lance Peterson, MD, FASCP, epidemiologist and a founder of the MRSA screening program at NorthShore University HealthSystem in Evanston, Ill. "The test showed good sensitivity with minimal hands-on time. Technicians now have the ability to have flexible batch sizes which could make it the cost-effective choice for many hospital laboratories."