FDA Clears Roche’s LightCycler Real-Time PCR Test for MRSA
Two-hour test is more sensitive than direct culture-based methods, firm claims.
FDA cleared Roche Molecular Systems’ LightCycler® MRSA Advanced Test for detecting methicillin-resistant Staphylococcus aureus (MRSA) in nasal swab samples. Performed on the LightCycler 2.0 real-time PCR instrument, the test generates results within two hours and has shown better sensitivity compared with direct culture-based methods, Roche claims. The test is provided in a ready-to-use format and designed for flexible batch sizes.
“Roche’s new LightCycler MRSA Advanced Test is designed to offer a simple, flexible, and reliable method for MRSA screening to support hospitals in the prevention of MRSA infections,” states Paul Brown, Ph.D., president and CEO at Roche Molecular Systems.
The firm says estimates suggest the market for molecular-based MRSA screening will be worth about $125 million in 2010 and is growing at a rate of some 20% annually. CDC estimates also quoted by Roche put the burdon of healthcare-associated infections at $4.5-$5.7 billion in the U.S. during 2007.
Roche is building a portfolio of molecular diagnostics for use on the LightCycler system. Tests available for clinical use include the LightCycler SeptiFast Test MGrade, which can detect the 25 most common microorganisms causing healthcare-associated sepsis. Samples testing positive for S. aureus using the the SeptiFast test can then be evaluated using the LightCycler® SeptiFast MecA Test MGrade, which specifically detects mecA DNA in human K-EDTA-blood. The MecA test is used as an aid to the detection of MRSA bloodstream infection in conjunction with clinical presentation, established microbiological assays and/or other laboratory markers.