FDA aproves new flu test

The U.S. Food and Drug Administration has cleared the ProFast+ assay for use as a simultaneous test for the seasonal A/H1, seasonal A/H3 and 2009 H1N1 strains of influenza.

Testing of ProFast+, which is manufactured by Prodesse, can yield results in less than four hours, GenomeWeb News reports. Gen-Probe called the quick testing time "a significant improvement over culture-based methods," GenomeWeb News reports. Culture-based testing methods often take several days to provide results.

“ProFast+ is a real-time multi-plex RT-PCR in vitro diagnostic test from nasopharyngeal swabs,” according to Prodesse’s parent company, Gen-Probe. ProFast+ uses the same format and internal control systems that other FDA-approved tests for respiratory illness by Prodesse use.

“[The clearance] kicks off what we believe will be an important new revenue growth cycle for Gen-Probe, as its 510(k) was the first of four U.S. regulatory applications that we expect to submit before year-end,” Carl Hull, CEO of Gen-Probe, told GenomeWeb News.

The ProFast+ assay is complemented by Prodesse’s ProFlu+ assay. ProFlu+ was cleared by the FDA in 2008 to identify H1N1 influenza and influenza A, but cannot differentiate between the subtypes of influenza A, while ProFast+ can. Other tests in existence for H1N1 are produced by Quest Diagnostics and the U.S. Centers for Disease Control and Prevention.