NEW YORK (GenomeWeb News) – Gen-Probe said on Monday that the US Food and Drug Administration has cleared Prodesse's ProFast+ assay, which makes it the only FDA-cleared molecular diagnostic test for the simultaneous detection of seasonal A/H1, seasonal A/H3, and 2009 H1N1.
The ProFast+ is a real-time, multiplex RT-PCR in vitro diagnostic test for detecting influenza A from nasopharyngeal swabs, and uses the same internal control and format as other FDA-cleared tests for respiratory infectious diseases made by Gen-Probe's Prodesse subsidiary. Results can be obtained in as little as four hours using the ProFast+ assay, which the company called "a significant improvement over culture-based methods" that can take days for results.
President and CEO Carl Hull said that 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 US regulatory applications that we expect to submit before year-end."
According to the company, the ProFast+ assay complements the Prodesse ProFlu+ assay that was cleared by the FDA in 2008. That test identifies samples containing 2009 H1NA as influenza A, but cannot differentiate among the various influenza A subtypes, as the ProFast+ can.
Other tests that have been cleared by the FDA specifically for 2009 H1N1 are from Quest Diagnostics and from the US Centers for Disease Control and Prevention.
Gen-Probe is scheduled to announce its second-quarter earnings on Thursday.