The Centers for Disease Control and Prevention (CDC) today announced $11.4 million in new contracts to four companies working to develop new diagnostic tests that doctors and field epidemiologists could eventually use to quickly and accurately test patients for avian influenza H5N1 and other emerging influenza viruses, as well as more common influenza viruses. The tests could provide public health experts worldwide with critical information on the influenza viruses circulating and help monitor for viruses that could cause a global influenza pandemic.
During the next year, the four companies will work to create tests that would detect seasonal human influenza viruses and differentiate influenza A H5N1 from seasonal human influenza viruses within 30 minutes. Because influenza viruses are constantly changing, the tests would also need to be quickly adapted if the virus mutates over time or if new viruses emerge that have the potential to cause a pandemic. In providing the funding, the CDC hopes to advance work that will enable the Food and Drug Administration (FDA) approval and commercialization of these products within two to three years.
"The creation of a point-of-care test to rapidly detect human cases of H5N1 avian influenza would be a major step forward in our ability to protect public health," Health and Human Services Secretary Mike Leavitt said. "If such a test can be developed, it will give us one more tool to keep up with the ever changing nature of influenza viruses."
"We have seen avian influenza infections since 1997 but we unfortunately still do not have a good way to quickly and easily distinguish at a patient's bedside whether they suffer from H5N1 or a more common type of influenza," said CDC director Julie Gerberding, MD, MPH. "These contracts will support development of promising technology that could help doctors treat their patients faster and help public health authorities track influenza viruses that could spur a pandemic."
Existing point-of-care tests can only determine if the patient is infected with seasonal influenza viruses A or B but cannot identify avian influenza H5N1. To test for H5N1, patient samples currently must be sent to one of about 100 designated labs nationwide that can perform specialized testing. The process can take four to 24 hours to complete, depending on shipping of samples.
The CDC, in partnership with the Department of Health and Human Services' Office of Public Health Emergency Preparedness, selected the four recipients from 13 applicants. The four were selected based on several criteria including: the technical specifications and projected performance characteristics of the test, experience in developing diagnostic tools, technical proficiency and staff expertise, and access to biosafety laboratories in which to work on H5N1, among others. In addition to these contracts, CDC will provide funding for a repository of influenza reagents and other materials to aid with the advanced development of these point-of-care diagnostics.
The companies, names of their tests and award amounts are listed below.
* Cepheid, Sunnyvale, Calif. - GeneXPert(r) Flu assay ($2.4 million)
* Iquum, Marlborough, Mass. - LIAT(tm), Lab-in-a-Tube ($3.8 million)
* MesoScale, Gaithersburg, Md. - Multi-ArrayTM Detection
* Nanogen, San Diego - a novel point of care immunoassay system
Since 2003, highly pathogenic avian influenza H5N1 has infected more than 250 people in 10 countries and resulted in more than 150 deaths. Nearly all cases have been caused by direct contact with infected poultry, and the virus is widespread in bird populations in Asia and parts of Africa and has been detected in Europe. In a few cases, there has been limited human to human transmission. However, the virus does not currently transmit easily from human to human. To date, highly pathogenic H5N1 avian viruses have not been found in the United States in either birds or humans.