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Response Biomedical Gets FDA OK for H1N1 Reactivity Info in Assay Package Insert

NEW YORK (GenomeWeb News) – Response Biomedical today said that the US Food and Drug Administration has granted a special 510(k) clearance to update the package insert on its RAMP Influenza A/B Assay Package Insert to include analytical reactivity information for the 2009 H1N1 flu virus.

The firm said that although the RAMP assay has been shown to detect the 2009 influenza A (H1N1) virus in cultured isolates, the performance characteristics of its test with clinical specimens that are positive for the virus have not been established. It said that the assay can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

The RAMP Influenza A/B Assay is marketed in the US by Response Biomedical's partner, 3M Healthcare, as the 3M Rapid Diagnostic Flu A+B Test, and is used to identify influenza A and B in human specimens.

"This clearance further validates our technology and combined with our recent RSV clearance will give 3M additional tools to promote the 3M Rapid Detection platform to hospitals, which help play a critical role in diagnosing and containing any upper respiratory infection outbreak," Response Biomedical CEO S. Wayne Kay, said in a statement.

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