Expression Analysis Introduces Proficiency Testing Program for Human RNA Samples.

DURHAM, N.C. -- Expression Analysis, a genetics testing/analysis company, offers the only proficiency testing program for gene expression microarrays. The program has already undergone three testing events on the Affymetrix platform using rat samples and participants are now being accepted for the upcoming rounds of human sample testing.

Microarrays measure RNA expression levels for thousands of genes simultaneously. Although the results can be affected by numerous parameters, little standardization and no certification process currently exist. The proficiency testing program developed and administered by Expression Analysis can be used to validate the performance of one laboratory by comparing it to others. Unlike other microarray data comparability studies, the proficiency testing program at Expression Analysis is repeated three times a year. This design allows participants to monitor their results over time.

Proficiency testing is particularly important to labs handling clinical samples or preparing for regulatory review. Clinical laboratories are required to participate in testing programs three times a year in order to maintain CLIA certification for some assays. In addition, the FDA has initiated a Microarray Quality Control project and may request microarray lab competency evaluations.

"Our clients gain significant benefits from our proficiency testing program," said Expression Analysis Founder and COO Steve Casey. "It offers them a means to validate their processes through direct comparisons with their peers at other microarray laboratories."

In the proficiency testing program, Expression Analysis sends replicates of two biologically different samples to participating laboratories. Each lab prepares biotin-labeled cRNA targets from the RNA samples and hybridizes them to Affymetrix GeneChips. The data are analyzed at Expression Analysis to determine the sensitivity and reproducibility of the assay as well as the comparability of the results between laboratories or in the same laboratory over time. All results are reported in a blinded fashion to maintain the anonymity of the participating labs.

Expression Analysis, Inc. (http://www.expressionanalysis.com/) is a full-service microarray genetics testing and analysis organization that provides high-quality genomic processing and data analysis services using Affymetrix GeneChip(R) technology. EA is one of the few U.S.-based authorized service providers for Affymetrix, Inc. Affymetrix' patented photolithographic manufacturing process provides the most information capacity available today on an array, enabling researchers to use a whole-genome approach to analyze the relationship between genetics and health.