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FDA, BioTrove Collaborate on Blood Screening

NEW YORK (GenomeWeb News) – The US Food and Drug Administration's Center for Biologics Evaluation and Research will investigate using BioTrove's Standardized NanoArray PCR (SNAP) gene expression profiling system for screening the nation's blood supply, BioTrove said today.

CBER's Division of Emerging and Transfusion Transmitted Diseases will fund BioTrove's efforts to adapt CBER's real-time, PCR pathogen assays to the SNAP system and conduct validation of the system's performance. BioTrove noted that its system is one of several platforms CBER is evaluating for high-throughput, multiplex detection of blood-borne pathogens.

BioTrove didn't name the other platforms being evaluated, and FDA officials did not respond to a request for more information by press time.

"Initial plans are to test several viruses, bacteria and parasites deemed priority infectious pathogens on the OpenArray SNAP platform, and contingent upon initial success, a second-year project may be proposed," BioTrove President and CEO Albert Luderer said in a statement.

The SNAP system detects multiple pathogens at one time from a single sample by combining BioTrove's OpenArray nanofluidic PCR platform with gene Express' Standardized RT-PCR standards method controls, and TaqMan fluorogenic probes.

Among the first pathogen tests to be adapted to the SNAP system are HIV, hepatitis B and C virus, poxvirus, West Nile Virus, Yersinia pseudotuberculosis, Bacillus anthracis, Leishmania, Trypanosoma, and Plasmodium.

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