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Asuragen Joins Industry Leaders in Completion of the FDA MAQC Project


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Asuragen, Inc. has announced its participation as an Affymetrix site for the U.S. Food and Drug Administration's Micro Array Quality Control (MAQC) Consortium, the results of which were published in an issue of Nature Biotechnology.

The goal of the project is to develop guidelines and quality control parameters for microarray data analysis.

"Selection as a test site for the MAQC signifies the high regard by which Affymetrix viewed Asuragen's Service capabilities and proven results," said Rollie Carlson, President of Asuragen.

"High quality, consistent data is critical for future applications of microarray data in pharmacogenomics and personalized healthcare."

Participation in the MAQC consortium demonstrates Asuragen's commitment to quality processes and results through its service offerings.

Data obtained through Asuragen's Gene Expression Profiling Service can be used to support Mandatory or Voluntary Genomic Data Submission guidelines, generate genomic data for Investigational New Drug (IND) or New Drug Applications (NDA), and explore biomarkers for clinical trials.

Asuragen's service capabilities include processes and conditions under which laboratory activities may be planned, performed, monitored, and reported to comply with relevant Good Laboratory Practices (GLP) requirements of 21 CFR Part 58.

According to Scott Hunicke-Smith, VP and GM of Asuragen Services, "The publications highlight Asuragen's bioinformatic prowess in the novel adaptation of power analysis to assess inter-lab and inter-platform performance."

The quality and consistency demonstrated by Asuragen's Affymetrix array processing contributed to the outstanding overall results of the Affymetrix platform.

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