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FDA and BioTrove Collaborate to Evaluate BioTrove’s Genetic Profiling and Pathogen Detection System
News

FDA and BioTrove Collaborate to Evaluate BioTrove’s Genetic Profiling and Pathogen Detection System

FDA and BioTrove Collaborate to Evaluate BioTrove’s Genetic Profiling and Pathogen Detection System
News

FDA and BioTrove Collaborate to Evaluate BioTrove’s Genetic Profiling and Pathogen Detection System

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BioTrove announced collaboration with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research to investigate the utility of the company’s Standardized NanoArray PCR (SNAP) gene expression profiling system for specific detection of pathogens in the nation’s blood supply.

CBER’s Division of Emerging and Transfusion Transmitted Diseases (DETTD) will fund BioTrove’s efforts to adapt the Center’s current real-time PCR pathogen assays to BioTrove’s SNAP system and to perform the technical validation of the SNAP system’s performance – one of several platforms that CBER is evaluating for high throughput, multi-plex detection of blood-borne pathogens.

FDA is interested in the SNAP system because of its potential to detect multiple pathogens at once in a single sample. Successful adaptation and validation of the system could help DETTD assist in the development of standardized, reproducible quantitative measurement tools to monitor the safety of the nation’s blood supply.

BioTrove’s SNAP system has the potential to detect multiple pathogens at one time in a single sample by combining BioTrove’s OpenArray nanofluidic PCR platform with Gene Express’s Standardized RT-PCR (StaRT-PCR) standards method controls, and TaqMan® fluorogenic-labeled probes.

The combined systems have shown initial success in providing researchers a dynamic range of standard real-time quantitative PCR in addition to simplifying the workflow and reducing the quantity of the test sample. These are important considerations for rapid and accurate determination of the safety of donated blood to be used in patients.

“BioTrove is committed to providing support and assistance to the DETTD as it carries out its own mission to protect the nation’s blood supply,” said Albert A. Luderer, Ph.D., President and CEO, BioTrove. “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.”

The first several DETTD pathogen tests to be adapted to the OpenArray SNAP system include:

Viruses: HIV, HCV, HBV, poxvirus, West Nile Virus
Bacteria: Yersinia pseudotuberculosis (model organism for Y. pestis), Bacillus anthracis (vaccine strain)
Parasites: Leishmania, Trypanosoma, Plasmodium.

The Standardized NanoArray PCR (SNAP) combines several high complexity, multi-gene diagnostic tests into a simple and easy to use diagnostic tool to accelerate and control PCR analysis of samples.
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