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Osmetech Submits Request to FDA for Swine Flu Test

NEW YORK (GenomeWeb News) – UK-based molecular diagnostics company Osmetech announced today that it has submitted a request to the US Food and Drug Administration for Emergency Use Authorization for its swine flu test.

The company's Respiratory Pathogen Test Panel detects 18 bacteria and viruses commonly involved in infection, including the influenza A virus and the H1N1 subtype linked to the recent swine flu pandemic.

The test is partially the result of an agreement inked between Osmetech and Qiagen last September, and is adapted from Qiagen's QIAplex-based respiratory test, said Osmetech. The new test is designed to run on Osmetech's eSensor XT-8 molecular diagnostics platform.

In late April, the FDA granted Emergency Use Authorization for the Centers for Disease Control and Prevention's rRT-PCR Swine Flu Panel.

Osmetech plans to launch the Respiratory Pathogen Test Panel as a research use only product next quarter. It is also in the process of developing an extension for the panel that further distinguishes between the human and swine forms of the H1N1 virus.

In a separate release issued today, Novato, Calif.-based Biosearch Technologies said that it is offering rapid custom synthesis of research use only oligonucleotide probes and primers that compose the CDC's swine flu test panel. The firm noted that its Black Hole Quencher dyes are used with the probes in the panel.

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