Affymetrix Participates in Study to Advance MicroArray Technology Towards Widespread Clinical Use
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Affymetrix Inc. has announced the publication of the MicroArray Quality Control (MAQC) study, a collaborative effort led by the FDA that included 137 scientists from private and public sector laboratories.
Affymetrix and other microarray and reagent manufacturers participated in the two-year initiative designed to address the reproducibility of data generated from microarrays.
The study, published in the Sept. 8, 2006 issue of Nature Biotechnology, demonstrated that at a high level, gene expression signatures generated by microarrays are repeatable, further advancing the field towards widespread use in clinical applications.
"The MAQC study has demonstrated that by practicing good scientific method in the laboratory, researchers can obtain accurate, reproducible data from microarrays," said Janet Warrington, Ph.D., vice president, Emerging Markets and Molecular Diagnostics R&D at Affymetrix, who co-authored three of the eight manuscripts published as part of the study.
"Microarrays are an important tool for advancing personalized medicine, drug target discovery, toxicogenomics and related fields, and this study supplies valuable performance information supporting the expansion of genomics in clinical applications."
In addition to advancing the field as a whole, the data obtained from the study showed that Affymetrix GeneChip® arrays demonstrated the reproducibility within and across sites, an element critical for the success of clinical studies.
Affymetrix GeneChip arrays also showed the apparent power in detecting changes in gene expression, better enabling the discovery of novel biomarkers that are the objective of many disease-related studies.
"The MAQC study clearly shows why GeneChip technology is considered the gold standard in the microarray industry-Affymetrix provides the highest quality and value for microarray-based research," said Lianne McLean, senior director, Academic Product Marketing at Affymetrix.
"We encourage the scientific community to read the manuscripts and to review the data. The results of the study speak for themselves."
Affymetrix outperformed other study participants in the following areas:
- Affymetrix technology demonstrated the highest level of reproducibility and consistency within and across different test sites, an element critical for the success of any clinical study.
- Affymetrix was shown to have the platform-it was the only manufacturer that did not remove or repeat data from any sites.
- Affymetrix technology demonstrated the apparent power, or sensitivity, in detecting changes in gene expression.
- Affymetrix is the participating platform that is designed to provide a comprehensive panel of controls, which is critical for the evaluation of clinical samples.
To generate the data for the study, six microarray manufacturers and the National Cancer Institute each selected three sites to run assays.
At each site, 20 RNA samples were processed, for a total of 60 samples for each participant.
The FDA analyzed the data using each vendor's recommended software, and compared the results.
The Affymetrix UserForum will feature continuing coverage of the MAQC study, including an interview with Dr. Warrington and a series of conference call symposia featuring other authors of the study.
