Expression Analysis offers microarray processing, analysis and data management services to pharmaceutical, biotechnology and diagnostic companies that require microarray data generation for regulatory submissions.
We have entered into several collaborations with the US Food and Drug Administration (FDA) to promote a better understanding of the capabilities of microarray-based gene expression data.
Microarray Quality Control Project
The Microarray Quality Control (MAQC) project is an FDA-led initiative. In Phase I of the project, MAQC participants demonstrated the comparability of expression results results generated on multiple microarray and alternative gene expression technologies. Expression Analysis was one of the official analysis sites. In fact, Dr. Wendell Jones, our Senior Director of Bioinformatics & Statistics, guided and personally performed much of the MAQC data analysis. Dr. Laura Reid, our Senior Director of External Scientific Affairs, led the main manuscript writing team for the Phase I publications and wrote the note on nomenclature.
Dr. Jones is on the Steering Committee for Phase II of the project and participates on most of the five working groups. Dr. Jones is one of the co-leaders of the MAQC-II Clinical Working Group and directs the Microarray Quality Subcommittee.
Click here for the technical note, MAQC Project
Download MAQC publications in Nature Biotechnology
Read the press release, Expression Analysis Participates in MicroArray Quality Control Project
Cancer Biomarkers Collaborative
The Cancer Biomarkers Collaborative (CBC) is under the leadership of the FDA, AACR and NCI. It was established to help accelerate the translation of biologically based therapeutics into the clinic by facilitating the use of validated biomarker in trials and thereby advancing the FDA Critical Path Initiative. Dr. Laura Reid, our Senior Director of External Scientific Affairs, is an invited member of the Assay Validation Subcommittee. She leads the Quality System writing team.
Mock Submission
In 2003, Expression Analysis collaborated with the FDA and Schering Plough to prepare a mock data submission including microarray results. Using data from a rat toxicological study, the submission described potential quality control metrics, analysis methods and laboratory infrastructure requirements. This document was the first electronic submission of microarray data to the FDA. Much of the format, content and context in this mock submission were reflected in the FDA guidance document for pharmacogenomic data submissions.
Read IVD Technology article on Mock Regulatory Submissions Using Microarray Data
Read bio1NF0RM article on the FDA Collaboration
Read Genome News Network article on the FDA Collaboration
Mixed Tissue Reference RNA Material (MTRRM)
Drs. Jones and Reid are also members of an FDA project to develop reference material for rat toxicology studies. Our company has contributed a data set of almost 300 hybridizations to this effort.
Read article,
Use of a mixed tissue RNA design for performance assessments on microarray formats
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FDA Collaborations