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NEW YORK (GenomeWeb) – Quest Diagnostics business Focus Diagnostics today said that the US Food and Drug Administration has cleared eight additional influenza strains on the Simplexa Flu A/B & RSV Direct kit. 

The kit originally received 510(k) clearance in 2012. The additional flu strains cleared by the FDA are H7N9; H3N2 (both the Minnesota and Indiana strains; H1N1 (2011); H3N2 (the Ohio and Texas strains); and influenza B (Brisbane and Wisconsin strains). 

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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.