Gene Express Inc

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 [101,102], and by the Clinical Laboratory Improvement Act of 1988 (CLIA) as necessary to support diagnostic testing [1]. 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