The Simplexa Flu A/B & RSV Direct Kit from Cypress, Calif.-based Focus Diagnostics—the products business of Madison, N.J.-based Quest Diagnostics—has received 510(k) clearance from the FDA for 46 additional influenza A and influenza B virus strains and seven 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. Those include all four influenza strains the World Health Organization recommends be included in vaccines during the Northern Hemisphere’s 2015-16 influenza season.
In addition, the 46 new influenza strains include 20 avian influenza A and two swine influenza virus strains. Those may be increasingly important to detect, as avian and swine influenza viruses 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,” said Michelle Tabb, Ph.D., vice president of research and development for Focus. “We are particularly gratified that we have validated recently circulating influenza viruses before this year’s flu season takes off, and that we have expanded our avian influenza detection claims.”
Influenza occurs globally, affecting up to 10% of adults and 30% of children, according to the World Health Organization statistics. According to the Centers for Disease Control and Prevention, most seasonal flu activity in the Northern Hemisphere occurs between October and May, with peak season in the United States between December and February.