FDA clears Simplexa for 2015-2016 flu season
The clearing allowed the test to include an additional 53 new virus strains for the upcoming season. This molecular test, developed by Quest Diagnostics’ products business known as Focus Diagnostics, is now the first FDA-cleared molecular test to identify so many viral strains at once.
"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," Dr. Michelle Tabb, vice president of research and development for Focus Diagnostics, said. "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."
In July 2012, the FDA gave the Simplexa test kit 510(k) initial clearance for specific virus strains and also some new strains in 2014. With this most recent clearance, now the test can identify even more viral strains, including the four influenza strains that the World Health Organization (WHO) recommends for vaccines during the influenza season.