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Roche Gets FDA OK for MDx MRSA Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Roche said after the close of the market Thursday that the US Food and Drug Administration has cleared its LightCycler MRSA Advanced Test for detection of methicillin-resistant Staphylococcus aureus.

The PCR-based test is a qualitative in vitro diagnostic test for direct detection of nasal colonization with bacterial MRSA. It is designed to aid in preventing and controlling MRSA infections in healthcare settings and can provide results within two hours, said Roche.

The test is run on Roche's LightCycler real-time PCR instrument.

Last month, the FDA cleared for marketing Cepheid's latest test for MRSA, the Xpert SA Nasal Complete. That test is designed for the detection and differentiation of Staphylococcus aureas and methicillin-resistant Staphylococccus aureus colonization in under one hour, according to Cepheid.

Becton Dickinson also makes a molecular MRSA test that identifies and differentiates Staphylococcus aureas and methicillin-resistant Staphylococccus aureus.