Gen-Probe, a provider of molecular diagnostic tests, has received FDA clearance for marketing Prodesse ProFAST+ assay, an in-vitro diagnostic test used to simultaneously detect and differentiate three common influenza A virus subtypes like seasonal A/H1, seasonal A/H3, and 2009 H1N1.
The ProFAST+ assay is a multiplex, real-time RT-PCR (polymerase chain reaction) test that detects influenza A from nasopharyngeal swabs. It uses the same internal control and format as other FDA-cleared Prodesse tests for respiratory infectious diseases, and easily integrates into a laboratory’s existing workflow.
Gen-Probe said that all Prodesse products have been optimised for use with automated extraction technology that minimises technician hands-on time. The test results can be obtained in just four hours using the ProFAST+ assay, advanced over culture-based methods that can take days to produce a result.
Accurate differentiation among the three influenza A subtypes is necessary because each subtype has a different susceptibility to commonly used influenza antiviral drugs.
According to Genprobe, the ProFAST+ assay complements the Prodesse ProFlu+ assay, which was cleared by the FDA in 2008 to detect and differentiate influenza A, influenza B, and respiratory syncytial virus (RSV).
The ProFlu+ assay identifies samples containing 2009 H1N1 as influenza A unlike the ProFAST+ test, which does not differentiate among the various influenza A subtypes.
Carl Hull, president and CEO of Gen-Probe, said: “FDA clearance of our ProFAST+ assay is important for public health, as the test enables physicians to accurately differentiate among influenza A subtypes that have different antiviral susceptibilities.
“In addition, the ProFAST+ 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.”