Focus Diagnostics’ influenza and respiratory syncytial virus molecular test has received clearance from the FDA for an additional 46 influenza A and influenza B strains and seven additional respiratory syncytial virus strains, according to a press release from its parent company, Quest Diagnostics.
In July 2012, the Simplexa Flu A/B & RSV Direct Kit initially was granted 510(k) clearance for select virus strains, and additional strains were cleared in 2014.
According to the company, the Simplexa test kit can now detect a combined 92 influenza and respiratory syncytial virus (RSV) strains, including the four influenza strains recommended by WHO to be included in the 2015-2016 quadrivalent influenza vaccine:
- A/Switzerland/9715293/2013 (H3N2)-like virus;
- A/California/7/2009 (H1N1)-like virus;
- B/Phuket/3073/2013-like virus; and
- B/Brisbane/60/2008-like virus.
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