Osmetech submits swine flu test to FDA

Osmetech has submitted a request to the FDA for emergency use authorization for its respiratory pathogen test panel test to be used to screen for the swine flu virus.

Osmetech said that its respiratory pathogen test panel test, which is expected to be launched as a research use only product in the next quarter of 2009, detects and differentiates between 18 common bacterial and viral infections, including the influenza A virus and its H1N1 subtype.

Osmetech is currently developing an extension to the respiratory pathogen test that will differentiate this H1N1 subtype between the human and swine forms of the virus.

Osmetech respiratory pathogen test panel test has been adapted from Qiagen’s QIAplex-based respiratory viral test for use on Osmetech’s eSensor XT-8 molecular diagnostics system, under the terms of an agreement signed in September 2008.

James White, CEO of Osmetech, said: We believe that our test is ideally suited for fast and reliable screening of influenza A virus types, including the swine flu strain which is currently a major pandemic concern. The test will be run on our eSensor XT-8 platform, which is a small, portable and easy to use platform that has the potential to enable testing to occur in numerous locations.