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FDA Clears Additional Flu Strains for Focus' MDx Assay

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). 

Focus said that the novel avian influenza A strain H7N9, which can kill as many as one-third of people it infects, and H3N2, which infects people more easily than other swine influenza virus according to the Centers for Disease Control and Prevention, are of particular concern.

"Influenza viruses constantly evolve, and virus subtypes can quickly develop and infect large populations," Hollis Batterman, medical director for infectious diseases at Focus, said in a statement. "It is vital that the tests can detect the recently circulating and geographically diverse strains."

The Simplexa Flu A/B & RSV Direct kit on the 3M Integrated Cycler is a real-time RT-PCR molecular test and was cleared for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus RNA in nasopharyngeal swabs from patients who show signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors.