Author: Saccomanno, Colette F

Source: Pharmacogenomics, Volume 7, Number 5, July 2006 , pp. 793-796(4)

Publisher: Future Medicine

Abstract:

Gene Express, Inc. is a technology-licensing company and provider of Standardized Reverse Transcription Polymerase Chain Reaction™ (StaRT-PCR™) services. Designed by and for clinical researchers involved in pharmaceutical, biomarker and molecular diagnostic product development, StaRT-PCR is a unique quantitative and standardized multigene expression measurement platform. StaRT-PCR meets all of the performance characteristics defined by the US FDA as required to support regulatory submissions <xref rid="ref-101 ref-102" ref-type="bibr">[101,102]</xref>, and by the Clinical Laboratory Improvement Act of 1988 (CLIA) as necessary to support diagnostic testing <xref rid="ref-1" ref-type="bibr">[1]</xref>. A standardized mixture of internal standards (SMIS™), manufactured in bulk, provides integrated quality control wherein each native template target gene is measured relative to a competitive template internal standard. Bulk production enables the compilation of a comprehensive standardized database from across multiple experiments, across collaborating laboratories and across the entire clinical development lifecycle of a given compound or diagnostic product. For the first time, all these data are able to be directly compared. Access to such a database can dramatically shorten the time from investigational new drug (IND) to new drug application (NDA), or save time and money by hastening a substantiated `no-go' decision. High-throughput StaRT-PCR is conducted at the company's automated Standardized Expression Measurement (SEM) Center™. Currently optimized for detection on a microcapillary electrophoretic platform, StaRT-PCR™ products also may be analyzed on microarray, high-performance liquid chromatography (HPLC), or matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) platforms. SEM Center™ services deliver standardized genomic data - data that will accelerate the application of pharmacogenomic technology to new drug and diagnostic test development and facilitate personalized medicine.

Keywords: contract research organization; gene expression measurement; gene expression profiling; genetic profiling; molecular diagnostics; PCR; personalized medicine; pharmacogenomics; StaRT-PCR™; transcript abundance

Document Type: Research article

DOI: http://dx.doi.org/10.2217/14622416.7.5.793

Affiliations: 1: Gene Express Inc., 975 Research Drive, Toledo, OH 43614, USA., Email: info@geneexpressinc.com

Publication date: 2006-07-01

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