ELITech Molecular Diagnostics earns FDA clearance for real-time commercial MRSA/SA test

September 1, 2012

ELITech Molecular Diagnostics has received FDA clearance for its MRSA/SA ELITe MGB test, a multiplex, qualitative real-time polymerase chain reaction assay for the detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from human nasal swab specimens.

Princeton, N.J. - ELITech Molecular Diagnostics has received Food and Drug Administration clearance for its MRSA/SA ELITe MGB test, a multiplex, qualitative real-time polymerase chain reaction (PCR) assay for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from human nasal swab specimens.

MRSA/SA ELITe MGB generates from 27 percent to 50 percent fewer missed MRSA infections when compared to published values of competing amplification methods, and three times fewer missed MRSA infections when compared to culture, the company states.

The assay combines ELITech’s MGB Technology and specific biomarkers that target conserved regions of a Staphylococcus aureus-specific gene (patent applied for) and the mecA gene. The combination of specific gene targets and MGB Technology enables accurate detection by avoiding primer/probe sequence mismatches due to mecA, SSCmec junction and spa gene heterogeneity inherent in other real-time PCR assays, according to company reports.