FDA clears real-time PCR molecular test for MRSA detection

Pleasanton, CA--  The FDA cleared Roche Molecular Systems, Inc.'s LightCycler MRSA Advanced Test, a  real-time polymerase chain reaction (PCR) test, for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the US.

Pleasanton, CA-- The FDA cleared Roche Molecular Systems, Inc.'s LightCycler MRSA Advanced Test, a real-time polymerase chain reaction (PCR) test, for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the US. The qualitative in-vitro diagnostic test directly detects nasal colonization with bacterial MRSA, and aids in the prevention and control of MRSA infections in healthcare settings, delivering results within two hours.

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 US, 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 HAIs.

Lance Peterson, M.D., FASCP, epidemiologist and a founder of the MRSA screening program at NorthShore University HealthSystem in Evanston, IL, said, "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."

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