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FDA and BioTrove Collaborate to Evaluate BioTrove's Novel Genetic Profiling and Pathogen Detection System for Possible Use in Detecting Threats to the Nation's Blood Supply.

CBER/FDA's Division of Emerging and Transfusion Transmitted Diseases to Evaluate the OpenArray PCR-Based SNAP System for Screening the Blood Supply for Viruses, Bacteria and Parasites

WOBURN, Mass. -- BioTrove announced a collaboration with the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services.  to investigate the utility of the company's Standardized NanoArray PCR PCR polymerase chain reaction.

PCR
abbr.
polymerase chain reaction


Polymerase chain reaction (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) 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 RT-PCR

reverse transcriptase-polymerase chain reaction. See PCR1.
 (StaRT-PCR) standards method controls, and TaqMan([R]) 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , HCV HCV
abbr.
hepatitis C virus


HCV 1 Hepatitis C virus, see there 2. Human coronavirus. See Coronavirus.
, HBV HBV hepatitis B virus.

HBV
abbr.
hepatitis B virus
, poxvirus poxvirus

Any of a group of viruses responsible for a wide range of pox diseases in humans and other animals. Poxvirus was the cause of smallpox. (Human chickenpox is caused by varicella-zoster virus.
, West Nile Virus West Nile virus, microorganism and the infection resulting from it, which typically produces no symptoms or a flulike condition. The virus is a flavivirus and is related to a number of viruses that cause encephalitis.  

* Bacteria: Yersinia pseudotuberculosis (model organism for Y. pestis), Bacillus anthracis (vaccine strain)

* Parasites: Leishmania Leishmania /Leish·ma·nia/ (lesh-ma´ne-ah) a genus of parasitic protozoa, including several species pathogenic for humans. In some classifications, organisms are placed in four complexes comprising species and subspecies: L. , Trypanosoma, Plasmodium plasmodium, name for a stage in the life cycle of a slime mold. Also, Plasmodium is the name given to the genus of the protozoan parasite that causes malaria.  

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 "Not invented here." See digispeak.

NIH - The United States National Institutes of Health.
) grant awarded in July 2008, the profiling test combines BioTrove's OpenArray([R]) nanofluidic polymerase chain reaction polymerase chain reaction (pŏl`ĭmərās') (PCR), laboratory process in which a particular DNA segment from a mixture of DNA chains is rapidly replicated, producing a large, readily analyzed sample of a piece of DNA; the process is  (PCR) technology platform, Gene Express standards for accurate and consistent PCR measurement, and the clinical expertise of the University of Rochester The University of Rochester (UR) is a private, coeducational and nonsectarian research university located in Rochester, New York. The university is one of 62 elected members of the Association of American Universities.  School of Medicine and Dentistry to create the SNAP gene expression profiling system.

About BioTrove, Inc.

BioTrove, Inc. offers two innovative technology platforms: OpenArray([R]), which advances genomic research in a wide range of life science fields, including agriculture, disease research, and public health, and RapidFire([R]), 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([R])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([R]) OpenArray([R]) 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([R]) 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.

About DETTD

The Division of Emerging and Transfusion Transmitted Diseases 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([R]) is a registered trademark of Roche Molecular Systems, Inc.

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Date:Sep 8, 2009
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