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mick

12/21/05 11:24 PM

#125 RE: mick #124

Inverness Medical clarifies its statement regarding Avian Flu claim (IMA) 22.71 +0.34:Co announced that its wholly owned subsidiary, Binax had obtained FDA clearance for inclusion of an avian influenza claim for its BinaxNOW Influenza A & B Test. Inverness recognizes that the title of the announcement and the description of the new claim may be interpreted to mean that the test has been demonstrated to work with human clinical specimens. Due to the scarcity of avian influenza in the human population, clinical specimens are not broadly available to the medical diagnostics test industry. As with other flu tests on the market, the ability of the BinaxNOW Influenza A&B Test to detect influenza A virus in human samples from patients infected with the H5N1 virus has not been established. However, in a recent analytical study, Binax demonstrated the reactivity of the BinaxNOW Influenza A & B Test with two isolates of H5N1 influenza that had been cultured in mammalian cells. These isolates have been added to the analytical reactivity section of its product labelling.