Celera Genomics receives $900,000 grant to develop avian flu diagnostic test

By E. Janene Geiss

Philadelphia, Aug. 21 - Celera Genomics, an Applera Corp. business, announced Monday that the National Institutes of Health has awarded Celera about $900,000 to develop and commercialize an in vitro diagnostic test for the highly pathogenic influenza A/H5 virus (Asian lineage, H5N1).

The test Celera said it plans to develop will be based on the Primer and Probe Set and protocols used in the test from the Health and Human Services' Centers for Disease Control and Prevention recently cleared by the Food and Drug Administration, according to a company news release.

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 said its 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 Laboratories, officials said.

"Early detection of avian influenza H5N1 in humans could allow for intervention with antiviral therapeutic drugs and institution of vaccination or quarantine strategies to prevent or delay spread of the infection," Tom White, chief scientific officer at Celera, said in the release.

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 Collaborating Center for Surveillance, Epidemiology and Control of Influenza, as well as with other interested laboratories.

The avian influenza test to be developed by Celera is expected to run on Abbott's new m2000 instrument system for detecting and monitoring infectious diseases, using automated real-time PCR technology from Applied Biosystems, officials said.

The m2000 is available in Europe with CE Mark certification and is pending 510 clearance with the FDA in the United States.

Applera, based in Rockville, Md., consists of two operating groups, Applied Biosystems Group and Celera Genomics. Celera is primarily a molecular diagnostics business that is using proprietary genomics and proteomics discovery platforms to identify and validate novel diagnostic markers.

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