Molecular diagnostics firm Osmetech has requested the FDA grant emergency-use authorisation for its respiratory pathogen test to be used to screen for the swine flu virus.
The 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 CEO James White said the company is confident that its test is ideally suited for fast and reliable screening of influenza A virus types, including the swine flu strain.
“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,” White said.
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.
The company’s proprietary 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.