NEW YORK (GenomeWeb News) – Celera Genomics today said it has received $900,000 from the US National Institutes of Health to develop and commercialize an in vitro diagnostic for detect the A/H5 influenza virus.
Celera said it plans to develop the test using the primer, probe set, and protocols used by US Health and Human Services' Centers for Disease Control and Prevention, whose IP was recently cleared by the US Food and Drug Administration.
Celera said it will license the CDC’s H5N1 assay information and sell the test through its alliance with Abbott.
Celera said it expects the test to run on Abbott's new m2000 system for detecting and monitoring infectious diseases and use 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.
The CDC’s assay is the only FDA-cleared test that detects the H5N1 virus, and its use is limited to labs designated by the Laboratory Response Network, Celera said.