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FDA Clears BioMérieux's MRSA Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – BioMérieux today announced that its automated molecular test for methicillin-resistant Staphylococcus aureaus has received 510(k) clearance from the US Food and Drug Administration.

The NucliSens EasyQ MRSA test detects seven MRSA types, covering the most prevalent strains, and also simultaneously detects two targets. BioMérieux's EasyQ system, the company said, will support efficient batch processing of up to 46 MRSA screening tests with a turnaround time of three hours.

The test, which is complementary to the French firm's culture-based chromID MRSA screen, was cleared with a clinical sensitivity of 94.7 percent and a clinical specificity of 96.5 percent in nasal samples from adult patients. It also was cleared with a clinical sensitivity of 100 percent and a clinical specificity of 97.3 percent in nasal samples from pediatric patients.

BioMérieux said that in the US MRSA infections kill about 19,000 individuals each year. If MRSA patients are identified and isolated the frequency of MRSA transmission is reduced by 38-fold, studies have shown, and systematic infection control measures, such as MRSA screening, can reduce the MRSA rate by 50 percent.

Other companies that have FDA-cleared molecular assays for MRSA include Roche and Cepheid.

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