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NEW YORK – Luminex said today that the US Food and Drug Administration has granted 510(k) clearance for its the real-time PCR-based Aries MRSA Assay running on its Aries sample-to-answer system.

The FDA has cleared the test for the direct detection of methicillin-resistant Staphylococcus aureus DNA from nasal swabs in patients at risk for nasal colonization.

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As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.