Tuesday, diagnostic products maker Gen-Probe Inc. (GPRO) said its subsidiary Prodesse has received clearance from the U.S. Food and Drug Administration for marketing ProParaflu Plus assay, a molecular test that detects and differentiates parainfluenza 1, 2, and 3 viruses that cause lower respiratory tract infections.
San Diego, California-based Gen-Probe said the ProParaflu Plus assay uses real-time polymerase chain reaction to identify parainfluenza 1, 2, and 3 viruses from nasal swabs. As the assay uses the same internal control as Prodesse's other tests for respiratory infectious diseases, a single nucleic acid extract can be tested with any combination of its other FDA-approved products, namely ProFlu Plus, Pro hMPV Plus, and ProFlu-ST.
FDA approved ProFlu Plus in 2008 to detect and differentiate influenza A and B viruses and respiratory syncytial virus. Pro hMPV Plus was cleared in the same year to detect human metapneumovirus. ProFlu-ST is available under an FDA emergency use authorization for use in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection.
Eric Tardif, senior vice president of Gen-Probe, said, "FDA clearance of our 510(k) application for ProParaflu+ adds to Prodesse's portfolio of molecular tests for respiratory infectious diseases. 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."
Test results using Prodesse assays can be obtained within three hours, compared to culture-based methods that take up to a week to produce a result, the company noted.
GPRO closed Tuesday's regular trading at $42.42, up $0.02 or 0.05%, on a volume of 228 thousand shares on the Nasdaq.
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