FDA provides marketing clearance for Prodesse's ProParaflu+ assay

Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProParaflu+(TM) assay, a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections.

Prodesse is a wholly-owned subsidiary of Gen-Probe, a global leader in molecular diagnostics.

"FDA clearance of our 510(k) application for ProParaflu+ adds to Prodesse's portfolio of molecular tests for respiratory infectious diseases," said Eric Tardif, Gen-Probe's senior vice president of corporate strategy and general manager of Prodesse. "Although parainfluenza virus infections aren't serious in most people, they can cause dangerous complications in young children, the elderly and other patient groups. We believe our assay will be an important tool to help physicians accurately identify these infections, especially when the prevalence of other viruses is high."

The ProParaflu+ assay uses real-time RT-PCR (polymerase chain reaction) to identify the parainfluenza 1, 2 and 3 viruses from nasal swabs. The assay uses the same internal control as Prodesse's other tests for respiratory infectious diseases, so a single nucleic acid extract can be tested with any combination of these products. Prodesse markets these respiratory tests in the United States:

• ProFlu+(TM), which received FDA clearance in 2008 to detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
• Pro hMPV+(TM), which received FDA clearance in 2008 to detect human metapneumovirus.
• ProFlu-ST(TM), which is available under an FDA emergency use authorization (EUA) to be used in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, from a single sample in individuals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices.

The real-time RT-PCR technology used in Prodesse's assays is simple to use and easily integrates into a lab's existing workflow. All products have been optimized for use with automated extraction technology that minimizes technician hands-on time. This ease-of-use enables labs to quickly validate the products. Test results can be obtained in as little as three hours using the assays - a significant improvement over culture-based methods that can take up to weeks to produce a result.