Bird Flu: Science and Policy

[Biowatch]

Celera Genomics Receives NIH Grant to Develop and Commercialize Avian Flu Diagnostic Test
Monday August 21, 7:00 am ET

ROCKVILLE, Md.--(BUSINESS WIRE)--Aug. 21, 2006--Celera Genomics (NYSE:CRA - News), an Applera Corporation business, today 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). 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.

"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," said Tom White, Ph.D., Chief Scientific Officer at Celera. "An accurate, standardized, and robust test would enable testing in more locations, and most importantly, enable investigators to make meaningful comparisons between laboratories quickly and reliably across the globe. The assay format that we're developing is expected to be suitable for widespread testing should a pandemic occur."

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.

"We have a track record of developing and commercializing molecular diagnostic tests for human viral pathogens based on real-time PCR technology, which specifically and rapidly detects and quantifies low levels of pathogens," said Michael Zoccoli, Ph.D., Vice President of Development at Celera. "The information from the CDC's FDA-cleared test and their vast influenza strain and specimen collection, combined with Celera's diagnostic product development and manufacturing expertise, should drive rapid progress on a test that could be broadly used in the event of a pandemic."

The avian influenza test to be developed by Celera is expected to run on Abbott's new m2000(TM) instrument system for detecting and monitoring infectious diseases, using automated real-time PCR technology from Applied Biosystems. The m2000 is currently available in Europe with CE Mark certification and is pending 510(k) clearance with the FDA in the United States.



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