Osmetech Submits Swine Flu Test To The FDA

Main Category: Swine Flu
Also Included In: Flu / Cold / SARS;  Regulatory Affairs / Drug Approvals;  Infectious Diseases / Bacteria / Viruses
Article Date: 19 May 2009 - 0:00 PDT


Osmetech (LSE:OMH) announced that it has submitted a request to the US FDA for Emergency Use Authorization (EUA) for its Respiratory Pathogen Test Panel test to be used to screen for the swine flu virus.

Osmetech's Respiratory Pathogen Test Panel test, which is expected to be launched as a research use only (RUO) product next quarter, 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, Chief Executive, Osmetech plc, 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."

About Swine Flu

Swine flu (swine influenza) is a highly contagious respiratory disease of pigs, caused by one of several swine influenza A viruses. Since pigs can be infected with more than one virus type at a time, genes of several viruses from various sources (including humans) can mix, allowing the swine influenza viruses to cross species barrier and eventually cause disease in humans. The clinical symptoms then are similar to seasonal influenza and other acute upper respiratory tract infections, in some cases leading to severe pneumonia and resulting in death. However, since mild or asymptomatic cases may have escaped from recognition, the true extent of this disease among humans is still unknown. Currently, there is no human vaccine on the market which protects against swine influenza. Antiviral drugs are available in many countries. More information on the swine flu is available on http://www.who.int/.

Source
Osmetech plc

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