The Simplexa Flu A/B and RSV direct kit has received premarket notification clearance from the Food and Drug Administration for additional influenza and RSV strains.
FDA granted initial 510(k) clearance to the Simplexa test kit for select virus strains in July 2012 and clearance of some additional strains in 2014. With the most recent clearance, the Simplexa test can detect a total of 92 influenza and RSV virus strains, including all four influenza strains the World Health Organization recommends be included in vaccines during the Northern Hemisphere’s upcoming influenza season: A/California/7/2009 (H1N1)-like virus, A/Switzerland/9715293/2013 (H3N2)-like virus; B/Brisbane/60/2008-like virus; and B/Phuket/3073/2013-like virus.
In addition, the 46 new influenza strains include 20 avian influenza A and two swine influenza virus strains, which can carry over into human populations.
“With the influenza virus constantly evolving year after year and the potential to infect large populations, it’s critical that physicians have access to tests to aid the detection of newly circulating and geographically diverse strains,” says Michelle Tabb, PhD, vice president of research and development at Focus Diagnostics. “We are particularly gratified that we have validated recently circulating influenza viruses—including the Switzerland, California, Phuket and Brisbane strains—before this year’s flu season takes off, and that we have expanded our avian influenza detection claims.”
