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Focus Diagnostics receives FDA clearance for flu, RSV test

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Focus Diagnostics’ influenza and respiratory syncytial virus molecular test has received clearance from the FDA for an additional 46 influenza A and influenza B strains and seven additional respiratory syncytial virus strains, according to a press release from its parent company, Quest Diagnostics.

In July 2012, the Simplexa Flu A/B & RSV Direct Kit initially was granted 510(k) clearance for select virus strains, and additional strains were cleared in 2014. According to the company, the Simplexa test kit can now detect a combined 92 influenza and respiratory syncytial virus (RSV) strains, including the four influenza strains recommended by WHO to be included in the 2015-2016 quadrivalent influenza vaccine — A/Switzerland/9715293/2013 (H3N2)-like virus; A/California/7/2009 (H1N1)-like virus; B/Phuket/3073/2013-like virus; and B/Brisbane/60/2008-like virus.

“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,” Michelle Tabb, PhD, vice president of research and development for Focus Diagnostics, said in the release. “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.”

The Simplexa test kit is a real-time PCR molecular test for the in vitro identification of influenza A, influenza B and RSV RNA in nasopharyngeal swabs from patients with signs and symptoms of respiratory tract infection along with clinical and epidemiological risk factors. It has been categorized as moderate complexity under the Clinical Laboratory Improvement Amendments. According to Quest Diagnostics, the test can produce results in approximately 1 hour.

Disclosure: Tabb is a paid employee of Focus Diagnostics.