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Luminex Submits MRSA Assay for FDA Clearance

This article has been updated from a previous version to clarify that Luminex's assay is qualitative.

NEW YORK – Luminex announced after the close of the market on Monday that it has submitted an application for clearance to the US Food and Drug Administration for its Aries MRSA Assay.

The assay is a real-time, qualitative polymerase chain reaction test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization.

The Luminex Aries instrument is a sample-to-answer, real-time system designed to increase laboratory efficiency and fit seamlessly into the modern laboratory, the firm said. The system has six FDA and seven CE-IVD cleared assays and can run laboratory-developed tests.

Homi Shamir, president and CEO of Luminex, said in a statement that the FDA submission demonstrates the firm's continued dedication to expanding its menu of "clinically relevant and high-value tests" on its sample-to-answer platforms. 

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