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.