The NCI-Funded Standardized Expression Measurement (SEM) Center(TM) Based on StaRT-PCR(TM) Enables Multi-Institutional Clinical Trials and Facilitates Development of Drugs and Molecular Diagnostic Tests
Posted on: Wednesday, 10 November 2004, 03:00 CST
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The NCI-Funded Standardized Expression Measurement (SEM) Center(TM) Based on StaRT-PCR(TM) Enables Multi-Institutional Clinical Trials and Facilitates Development of Drugs and Molecular Diagnostic Tests. Terry W. Osborn, James C. Willey, Charles R. Knight, Cheryl A. Motten, Bradley J. Austermiller, Elizabeth A. Herness Peters, Robert J. Zahorchak, and Andy Bass. Medical College of Ohio, Toledo, OH and Gene Express, Inc., Toledo, OH.
Measuring expression of multiple genes in cell or tissue samples holds the promise of augmenting morphologic analysis and thereby facilitating development of drugs and molecular diagnostic tests through more meaningful classification. Advances in this area will depend on expression measurement methods that are standardized, reproducible, gene-specific, and sensitive. These properties are necessary for comparison of data across studies, analysis of small clinical diagnostic specimens, development of a reference data base necessary for meaningful diagnostic testing, and compliance with requirements established by regulatory agencies. Through NCI- fiinding (CA 95806), we have established the Standardized Expression Measurement (SEM) Center. The SEM Center uses a robotic liquid bandler to prepare standardized RT (StaRT)-PCR reactions in 96-well microplates, followed by PCR-amplification in multi-block thermocyclers, then high throughput electrophoretic separation and quantification in a Caliper LabChip 90 microfluidic capillary electrophoresis device. The system is linked through proprietary software and programs in Microsoft (MS) Access, MS Excel, and MS Visual Basic for Applications. With implementation of these programs and establishment of standard operation procedures over the last year the throughput in gene expression assays/day has increased from 100 to over 1,000 and CV has decreased from 35% to less than 10%. Further, the SEM Center has successfully completed projects for multi-institutional trials, drug development and diagnostic testing. Moreover, the reference database is growing rapidly and now includes gene expression data from normal and/or malignant human lung, liver, kidney, spleen, uterus, ovary, bladder, blood and breast, as well as the Stratagcnc Reference RNA.
Copyright American Association for Clinical Chemistry Nov 2004
Source: Clinical Chemistry
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