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Related Experiment Videos

Gene Express Inc.

Colette F Saccomanno1

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

Pharmacogenomics
|August 5, 2006
PubMed
Summary
This summary is machine-generated.

Standardized Reverse Transcription Polymerase Chain Reaction (StaRT-PCR) offers a reliable method for multigene expression measurement. This platform supports regulatory submissions and diagnostic testing, accelerating drug development and personalized medicine.

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Area of Science:

  • Genomics
  • Molecular Biology
  • Biotechnology

Background:

  • Clinical researchers require reliable methods for pharmaceutical and diagnostic product development.
  • Existing gene expression platforms may lack standardization for regulatory and diagnostic applications.
  • Multigene expression measurement is crucial for understanding complex biological processes.

Purpose of the Study:

  • To introduce and describe the Standardized Reverse Transcription Polymerase Chain Reaction (StaRT-PCR) platform.
  • To highlight the platform's compliance with regulatory standards (FDA, CLIA).
  • To emphasize the benefits of standardized genomic data for accelerating drug and diagnostic development.

Main Methods:

  • StaRT-PCR utilizes a standardized mixture of internal standards (SMIS) for integrated quality control.

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  • High-throughput StaRT-PCR is performed at an automated Standardized Expression Measurement (SEM) Center.
  • Data can be analyzed on various platforms including microcapillary electrophoresis, microarray, HPLC, and MALDI-TOF.

    • Main Results:

    • StaRT-PCR provides quantitative and standardized multigene expression measurements.
    • The platform meets US FDA and CLIA performance requirements.
    • Bulk production of SMIS enables a comprehensive, standardized database for direct data comparison across experiments and laboratories.

    Conclusions:

    • StaRT-PCR facilitates direct comparison of genomic data, accelerating drug development timelines (IND to NDA).
    • The standardized database can expedite substantiated 'no-go' decisions, saving time and resources.
    • Standardized genomic data from SEM Center services accelerate pharmacogenomic technology application and personalized medicine.