Celera Genomics Receives NIH Grant to Develop and Commercialize Avian Flu Diagnostic Test
Celera Genomics, an Applera Corporation business, announced that the National Institutes of Health (NIH) has awarded Celera approximately $900,000 to develop and commercialize an in vitro diagnostic (IVD) test for the highly pathogenic influenza A/H5 virus (Asian lineage, H5N1). The test Celera plans to develop will be based on the Primer and Probe Set and protocols used in the test from the U.S. Health and Human Services' Centers for Disease Control and Prevention (CDC) recently cleared by the U.S. food and Drug Administration (FDA). According to the company, the CDC assay is the only FDA-cleared assay for detection of the H5N1 virus, and its use is limited to the laboratories designated by the Laboratory Response Network. Celera's access to the H5N1 assay information will be through a license to be obtained by Celera from the CDC. The test is expected to be sold through Celera's alliance with Abbott.
The grant will partially support a multi-phased, three year project. Performance testing and validation will be done in collaboration with the CDC, which has accumulated a large collection of influenza strains and clinical respiratory specimens as a World Health Organization (WHO) Collaborating Center for Surveillance, Epidemiology and Control of Influenza, as well as with other interested laboratories.
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