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Elitech Receives 510(k) Clearance for MRSA/SA Assay

NEW YORK (GenomeWeb News) – Elitech Molecular Diagnostics said today that the US Food and Drug Administration has cleared its multiplex, qualitative real-time PCR assay for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus DNA.

The test called MRSA/SA Elite MGB is for the direct detection of DNA purified from human nasal swab specimens and generates 27 percent to 50 percent fewer missed MRSA infections compared to published values of other amplification methods and three times fewer missed MRSA infections compared to culture-based methods, EliTech said.

The test is cleared for use on the BioMérieux NucliSens easyMag and Life Technologies' ABI 7500 Fast Dx instruments.

The assay uses proprietary MGB Technology and unique biomarkers that target conserved regions of a Staphylococcus aureus-specific gene and the mecA gene. The technology, the company said, allows for accurate detection by circumventing primer/probe sequence mismatches due to mecA, SSCmed junction and spa gene heterogeneity found in other real-time PCR methods.

According to Pierre Debiais, president and CEO of France-based EliTech Group, the MRSA/SA Elite MGB assay is the firm's first 510(k)-cleared molecular diagnostic. The company also has filed for FDA clearance of its C. difficile Elite MGB assay.

The EliTech Group manufactures and distributes diagnostic products for clinical chemistry, microbiology, immunology, and molecular biology.