bioMerieux Receives FDA Clearance for Automated, Rapid Molecular Screening Test for MRSA

bioMérieux, a leader in the field of in vitro diagnostics, announces that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its NucliSENS EasyQ® MRSA, an automated molecular test for methicillin-resistant Staphylococcus aureus (MRSA).

The test detects seven MRSA types,(1) covering the most prevalent strains. The test also simultaneously detects two targets, which provides added confidence to the screening results. The EasyQ system will support efficient batch processing of up to 46 MRSA screening tests in a compact space with a rapid turn-around time of only three hours. Real-time actionable results enable more informed clinical decisions, which play an essential role in the management of antimicrobial resistance. Helping clinicians to take faster action to isolate patients and limit transmission is a critical issue, since MRSA is one of the leading causes of healthcare-associated infections (HAIs). MRSA is also on the rise and has spread into the community. In the United States, MRSA infections alone kill nearly 19,000 people a year.(2) Studies have shown that the frequency of MRSA transmission is reduced 38-fold if patients are identified and isolated.(3) Systematic infection control measures, including MRSA screening, reduce the MRSA rate by 50%.(4)

"bioMérieux is committed to bringing innovative solutions to the microbiology lab that reduce the time to results so that clinicians can treat patients more rapidly," says Stéphane Bancel, bioMérieux CEO. "bioMerieux has the most comprehensive diagnostic product offering in the fight against MRSA, from chromogenic media to molecular assays. Our strategy is to lead the microbiology market by offering the greatest total value proposition for our customers and, at a time when reducing HAIs and related healthcare costs is paramount, we are proud to make a highly automated, rapid and cost-effective molecular MRSA screening solution available to U.S. clinicians."

NucliSENS EasyQ MRSA complements chromID

4. Harbarth S et al. Effect of delayed infection control measures on a hospital outbreak of methicillin-resistant Staphylococcus aureus. J Hosp Infect 2000; 46:43-49.3. Vriens MR et al. Is methicillin-resistant Staphylococcus aureus more contagious than methicillin-susceptible S. aureus in a surgical intensive care unit? Infect Control Hosp Epidemiol 2002; 23:491-4942. Klevens RM. et al. Invasive Methicillin-resistant Staphyloccus aureus infection in the United States. JAMA 2007; 298:1763-17711. MREJ types 1,2,3,4,5,7 and 12References:The NucliSENS EasyQ MRSA test was cleared with a clinical sensitivity of 94.7 percent and a clinical specificity of 96.5 percent when testing nasal samples from adult patients. Additionally, the assay also received clearance with a clinical sensitivity of 100 percent and a clinical specificity of 97.3 percent when testing nasal samples from pediatric patients.

MRSA, bioMérieuxs chromogenic media, which enables direct, color-specific visual observation of the bacterial colonies in patient samples. bioMérieux can now offer hospitals and healthcare providers cost-effective alternatives for both culture-based and molecular-based MRSA screening. The complete suite of bioMérieux MRSA solutions also includes VITEK® 2 for rapid identification and antibiotic susceptibility testing, Etest® for extended dilution MICs (minimum inhibitory concentration), and DiversiLab® for strain typing.