Focus Diagnostics, a unit of Quest Diagnostics ($DGX), announced that it has the FDA's 510(k) clearance for its Simplexa Flu A/B & RSV Direct Kit for 46 additional influenza A and B virus strains and 7 additional respiratory syncytial virus (RSV) strains.
The additional strains come on top of those granted clearance in 2014 and the original clearance of the Simplexa in 2012. Now, the Simplexa is cleared to detect 92 influenza and RSV virus strains, which the company claims is more than any other FDA-cleared molecular diagnostic in its class.
The influenza strains included all four of those recommended by the World Health Organization. The new strains include 20 avian influenza A and two swine influenza strains, according to a release.
"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, and that we have expanded our avian influenza detection claims."
Citing the World Health Organization, Focus says that 5% to 10% of adults and 20% to 30% of children are affected by influenza globally.
The company has had a number of recent approvals. In September, Focus Diagnostics nabbed FDA clearance to add a genital swab claim to the label of its rapid herpes test. And in April, the Cypress, CA-based company scored FDA 510(k) clearance for its Simplexa Group A Strep Direct test, which uses real-time PCR technology to pinpoint bacterial DNA and RNA from throat swabs in as little as an hour.
- read the release