FDA Approves Quest Influenza Test

The U.S. Food and Drug Administration (FDA) has granted approval to a Quest Diagnostics affiliate for a significantly expanded test for influenza and respiratory syncytial (RSV) virus.

The FDA granted clearance to Focus Diagnostics' Simplexa molecular assay for an additional 46 strains of the influenza A and the influenza B virus, including 20 avian and two swine flu strains. The real-time test can now detect 92 strains in total. The clearance also adds seven additional RSV strains. Nasal swabs are tested on a portable platform developed by 3M.

The FDA originally approved the assay in 2012, and approved some expansions last year.

The need for accurate testing has grown over the years in the U.S., particularly as the population has continued to age and is therefore more susceptible to influenza. Epidemiologists have also been concerned about the viruses mutating into a strain that causes a global pandemic such as the Spanish strain that killed some 50 million people in 1918. Influenza affects up to 10 percent of all adults and 30 percent of all children annually.

"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, vice president of research and development for Focus Diagnostics, in a statement. "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."

The timing of the FDA approval—just as the flu season begins in the United States—is particularly helpful for Quest. The approval did not lead to any significant fluctuations in Quest's stock.

Takeaway: Quest's Focus Diagnostics division appears to have the market lead on comprehensive influenza testing.