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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.