Since 2003, the highly pathogenic avian influenza H5N1 has infected 382 people and resulted in 241 deaths. Although the majority of cases have been caused by direct contact with infected poultry, there have been a few cases of human-to-human transmission, and experts fear the virus will mutate into a form that will be easily passed from person to person. "The early detection of emerging pandemic influenza is critical to the nation's pandemic response," said Mike Leavitt, U.S. Department of Health and Human Services (HHS) Secretary.
Secretary Leavitt has since announced that the Centers for Disease Control and Prevention (CDC) had awarded $12.9 million for the development of low-cost influenza tests to detect and differentiate seasonal human influenza viruses from avian influenza within three hours, according to the HHS press release. "Early detection will aid in improving patient survival, overall health outcomes, and use of containment measures in the event of an influenza pandemic," Leavitt said. Currently, the testing process for H5N1 can take up to 24 hours to complete.
The recipients of the contract awards, who were selected from among nine responses to the request for proposal, are: Nanogen, Inc, San Diego, California and Meso Scale Diagnostics, LLC, Gaithersburg, Maryland, each for $6.5 million for initial phased development. The contracts provide for funding up to $10.4 million (Nanogen, Inc.) and $12.1 million (Meso Scale Diagnostics, LLC) for additional development up to three years. The two contracts were awarded by the CDC in partnership with the Office of Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response.
The awards will support advanced development of laboratory influenza tests, which could be performed in a hospital or a commercial laboratory, and would expedite the diagnosis of large numbers of patients. The expanded testing capability will significantly enhance the hospital laboratory-based pandemic and seasonal flu diagnostic capacity in the United States.


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