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Expression
Analysis was incorporated in September of 2001
specifically to fill the market need for a high
quality supplier of microarray services and solutions.
In October of 2001, Expression Analysis gained
Duke University as its first customer. Duke University
chose to close its Affymetrix core facility to
take advantage of quality, cost and throughput
improvements offered by Expression Analysis.
Today, Expression Analysis is recognized as the
market leader in microarray outsourcing for gene
expression, genotyping and resequencing analysis.
Expression Analysis provides experimental design
consultation, biologic sample preparation, sample
processing and data/statistical analysis services
to clients worldwide. The Company's expertise
has expanded to assist companies utilizing microarray
technology in the incorporation of data to regulatory
agencies.
Expression Analysis has taken a leadership role
in establishing quality and regulatory standards
for microarray processing, analysis and data management.
The Company has established strict quality control
measures, has implemented auditable Standard Operating
Procedures (SOP's) to help minimize variability
and is compliant with 21 CFR Part 58 (Good Laboratory
Practices) and 21 CFR Part 11 (Electronic Records
and Signatures).
Also, in collaboration with the Food and Drug
Administration (FDA) and a major pharmaceutical
company, Expression Analysis has developed a format
for electronic submission of microarray-based
gene expression data and associated results. The
outcome of this work was the establishment of
regulatory initiatives using genomic data to accelerate
drugs and diagnostics through the FDA approval
process.
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