Prodesse

The PCR-based test for detecting and differentiating influenza types has received the green light for marketing in Europe.

Gen-Probe got the EUA for a test made by Prodesse for detecting H1N1.

The acquisition will provide Gen-Probe with FDA-cleared molecular assays for respiratory and infectious diseases.

Prodesse will market the SmartCycler along with its PCR tests in the US.

Prodesse can add claims to its assay regarding its ability to identify as Influenza A positive specimens conatining the 2009 H1N1 inlfuenza virus.

Rapid influenza diagnostic tests only detect the new H1N1 strain and other flu viruses between 40 and 69 percent of the time, according to a pilot study by CDC researchers.

The '989 "Caskey" patent, assigned to Baylor College of Medicine, covers molecular multiplexing and the '767 "Stanbridge" patent, assigned to the University of California, covers molecular detection of prokaryotic organisms, mostly bacteria.

Luminex, BD, and Prodesse all immediately complied with FDA's instructions in removing statements from their websites related to tests for the 2009 H1N1 flu virus.

Prodesse's assay will follow BD's moelcular diagnostic assay, which received FDA OK earlier this year.

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