Our overall goal is to develop, produce and register with the appropriate government regulatory agencies standardized diagnostic reagents for the real-time PCR-based detection of the Avian Influenza A viral pathogen (H5N1), as well as for all Influenza A pathogens (human and animal). This work will be performed in collaboration with scientists at the Centers for Disease Control. The diagnostic assay will be comprised of (1) the TaqMan PCR primers and probes designed by the Centers for Disease Control that are now supplied to public health laboratories for surveillance, diagnosis and research purposes, and (2) positive and negative controls. Development of these reagents by Celera Diagnostics under the FDA's Quality System Regulations will involve optimization of the reagents, process development, scale-up of reagent production under current Good Manufacturing Practice (cGMP) conditions, pre-clinical testing and validation of the assay, submission of a de novo 510k application for FDA clearance, and commercialization. Celera Diagnostics has experience in the development and commercialization of sensitive and specific PCR assays for the detection of viral pathogens. The development of robust, stable, manufactured reagents and their availability to public health laboratories and the World Health Organization will allow for widespread distribution and adoption of a standardized approach to surveillance and diagnosis of the Avian Influenza A pathogen H5N1. The availability of standardized reagents for the detection of Avian Influenza A subtype H5N1 will enable testing to be performed in more locations, and most importantly, results will be comparable between laboratories. In addition, the widespread availability of a sensitive and specific test for avian influenza H5N1 could help further basic research into the transmission and virulence of this pathogen, as well as being a tool for vaccine production. Early detection of avian influenza H5N1 in humans could allow for intervention with antiviral therapeutic drugs, vaccination or quarantines to prevent or delay international spread of the infection. Avian influenza H5N1 is a highly pathogenic form of influenza that currently has a severe economic impact upon affected countries due to a high avian fatality rate. To-date there have been few cases of human infections, however they had a 50% fatality rate. The virus is highly susceptible to genetic reassortment and mutation, and thus could rapidly become readily transmissible to humans. ? ? ? ?
