Sunday, November 29, 2009

FDA Evaluating BioTrove Standardized NanoArray PCR for Blood Supply Protection

BioTrove began a collaboration with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research in September 2009 to investigate the utility of the company’s Standardized NanoArray PCR (SNAP) gene expression profiling system for the rapid and specific detection of pathogens in the nation’s blood supply.

CBER’s Division of Emerging and Transfusion Transmitted Diseases (DETTD) is funding 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, multiplex 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. Developed in collaboration between BioTrove and Gene Express following the receipt of a two-year National Institutes of Health (NIH) grant awarded in July 2008, the profiling test combines BioTrove’s OpenArray® nanofluidic polymerase chain reaction (PCR) technology platform, Gene Express standards for accurate and consistent PCR measurement, and the clinical expertise of the University of Rochester School of Medicine and Dentistry to create the SNAP gene expression profiling system.

BioTrove, Inc. offers two innovative technology platforms: OpenArray®, which advances genomic research in a wide range of life science fields, including agriculture, disease research, and public health, and RapidFire®, which enables the acceleration of drug discovery and pipeline decisions. With 11 of the 12 largest biopharmaceutical companies based on global sales as clients, and partnerships with prestigious research and public health centers around the world, BioTrove's products and services ensure that an industry committed to accuracy and speed can meet business goals.

The OpenArray® Platform enables genomics researchers to generate SNP and real time qPCR data in the hundreds of thousands of data points per day, significantly increasing the number of samples analyzed while significantly decreasing the time and cost required. The flexible format and nanoliter scale of the OpenArray system allows for easy adjustment of sample and assay numbers, achieving economical, high-throughput genomics. Life Technologies globally markets the OpenArray SNP genotyping platform under the TaqMan® OpenArray® SNP Genotyping brand. BioTrove is a licensee of Life Technologies global patent rights related to the real-time thermal cyclers, microfluidics and data analysis.

RapidFire® Mass Spectrometry (RF-MS) feeds samples directly to the mass spectrometer at six to eight seconds per sample, eliminating the bottleneck created by traditional mass spectrometry throughput. RF-MS is routinely used in many applications including the high-throughput screening of previously intractable drug targets, ADME assays and directed evolution studies.

The Division of Emerging and Transfusion Transmitted Diseases (DETTD) plans and conducts research related to development, manufacture, pathogenesis, and testing of blood-borne pathogens. To ensure the safety of nation’s blood supply, DETTD reviews, evaluates, and recommends appropriate action on applications for licensure or clearance for blood screening and diagnostic tests, and develops policies related to their use. In addition, the division personnel provide expert scientific and technical advice and assistance to other Agency components, PHS agencies, advisory committees, blood establishments, and international and academic organizations on issues related to the safety and efficacy of blood donor screening testing products. The division also prepares policy-related documents such as presentations to the Blood Products Advisory Committee or Guidance Documents.

TaqMan® is a registered trademark of Roche Molecular Systems, Inc.


Dr. Colin Brenan, CTO
BioTrove, Inc.

FDA Office of Communication, Outreach and Development

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