Simplexa Flu A/B & RSV Direct Test receives FDA 510(k) clearance for 54 new virus strains- Focus Diagnostics

Focus Diagnostics announced that its Simplexa Flu A/B & RSV Direct Kit has received 510(k) clearance from the FDA for 46 additional influenza A and influenza B virus strains and 7 additional respiratory syncytial virus (RSV) strains. The FDA granted 510(k) initial clearance to the Simplexa test kit for select virus strains in July 2012 and clearance of some additional strains in 2014. With the recent clearance, the Simplexa test can detect a total of 92 influenza and RSV virus strains, more than any other FDA-cleared molecular test kit.

These include all four influenza strains the World Health Organization recommends be included in vaccines during the northern hemisphere's 2015-2016 influenza season: 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. In addition, the 46 new influenza strains include 20 avian influenza A and two swine influenza virus strains. These may be increasingly important to detect, as avian and swine influenza viruses can carry over into human populations.