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Executive Summary

[Word] [PDF]



The purpose of the MAQC project is to provide quality control tools to the microarray community in order to avoid procedural failures and to develop guidelines for microarray data analysis by providing the public with large reference datasets along with readily accessible reference RNA samples.

Project Description

FDA’s Critical Path Initiative identifies pharmacogenomics and toxicogenomics as key opportunities in advancing medical product development and personalized medicine, and the “Guidance for Industry: Pharmacogenomic Data Submissions” [PDF] [WORD] has been released. Microarrays represent a core technology in pharmacogenomics and toxicogenomics; however, before this technology can successfully and reliably be used in clinical practice and regulatory decision-making, standards and quality measures need to be developed.

The MicroArray Quality Control (MAQC) project involves six FDA Centers, major providers of microarray platforms and RNA samples, EPA, NIST, academic laboratories, and other stakeholders. The MAQC project aims to establish QC metrics and thresholds for objectively assessing the performance achievable by various microarray platforms and evaluating the advantages and disadvantages of various data analysis methods. Two RNA samples will be selected for three species, human, rat, and mouse, and differential gene expression levels between the two samples will be calibrated with microarrays and other technologies (e.g., QRT-PCR). The resulting microarray datasets will be used for assessing the precision and cross-platform/laboratory comparability of microarrays, and the QRT-PCR datasets will enable evaluation of the nature and magnitude of any systematic biases that may exist between microarrays and QRT-PCR. The availability of the calibrated RNA samples combined with the resulting microarray and QRT-PCR datasets, which will be made readily accessible to the microarray community, will allow individual laboratories to more easily identify and correct procedural failures.

The MAQC project will help improve the microarray technology and foster its proper applications in discovery, development and review of FDA regulated products. Everyone is invited to participate in the MAQC project.


February 11, 2005: Launch of Phase I of the MAQC project (MAQC-I) on microarray technical performance.

October 21, 2005:  Completion of MAQC main study (data generation).

December 1-2, 2005:  Face-to-face meeting in Palo Alto, California to discuss results on the analysis of the MAQC datasets.  View details (coming soon).

June 5, 2006: Submission of MAQC manuscripts.

September 8, 2006: Publication of MAQC results in Nature Biotechnology [Articles freely available].

September 8, 2006: Release of MAQC datasets to the public. [WORD] [PDF]

September 8, 2006: The MAQC datasets are publicly available [WORD] [PDF]

September 21, 2006: Launch of Phase II of the MAQC project (MAQC-II) on predictive classifiers (signatures).

End of 2008: Submission of MAQC-II manuscripts.

Early 2009: Publication of MAQC-II results.

Meeting Dates and Summaries

  • September 18-19, 2008, The 9th MAQC project face-to-face meeting was held at Silver Spring, MD. Final Agenda [PDF], Summary [PDF]
  • March 24-26, 2008, The 8th MAQC project face-to-face meeting was held at Rockville, MD. Final Agenda [PDF], Summary [PDF]
  • May 24-25, 2007, The 7th MAQC project face-to-face meeting was held at Cary, NC. Meeting announcement [Word] [PDF]. Final Agenda [Word] [PDF], Summary [Word] [PDF]
  • November 28-29, 2006, The 6th MAQC project face-to-face meeting was held at Washington, DC and Silver Spring, Maryland. Meeting announcement [Word] [PDF], Agenda [Word] [PDF], Summary [Word] [PDF]
  • September 21, 2006, 5th MAQC project face-to-face meeting was held at the FDA/NCTR, Jefferson, Arkansas from 8:30 am CDT to 3:00 PM CDT (open to the public). Agenda [Word]  [PDF], Summary [Word] [PDF]
  • September 8, 2006, The MicroArray Quality Control (MAQC) Project Summary [Word]  [PDF]
  • September 8, 2006, MAQC Phase I results were published in Nature Biotechnology.
  • May 18, 2006 (Teleconference), Summary [Word]  [PDF]
  • Federal Register notice - MAQC Follow-up on predictive signatures [ PDF]
  • May 4, 2006 (Teleconference), Summary [Word]  [PDF]
  • April 20, 2006 (Teleconference), Summary [Word]  [PDF]
  • April 6, 2006 (Teleconference), Summary [Word]  [PDF]
  • March 23, 2006 (Teleconference), Summary [Word]  [PDF]
  • March 20, 2006 (face-to-face meeting at San Diego, CA) [Word] [PPT]  [PDF]
  • March 9, 2006 (Teleconference), Summary [Word]  [PDF]
  • February 23, 2006 (Teleconference), Summary [Word]  [PDF]
  • February 9, 2006 (Teleconference), Summary [Word]  [PDF]
  • February 3-4, 2006 (face-to-face meting at Boston, MA). Meeting Agenda [Word] [PDF], Summary  [Word]  [PDF]
  • January 26, 2006 (Teleconference), Summary [Word]  [PDF]
  • January 12, 2006 (Teleconference), Summary [Word]  [PDF]
  • December 15, 2005 (Teleconference), Summary [Word]  [PDF]
  • December 1-2, 2005 (face-to-face meeting at Palo Alta, Ca).  Meeting Agenda [Word] [PDF], Summary  [Word]  [PDF]
  • November 17, 2005 (Teleconference), Summary [Word]  [PDF]
  • November 3, 2005 (Teleconference), Summary [Word]  [PDF]
  • October 20, 2005 (Teleconference), Summary [Word]  [PDF]
  • October 6, 2005 (Teleconference), Summary [Word]  [PDF]
  • MEETING NOTICE - The Food and Drug Administration (FDA) is announcing a public meeting entitled ``MicroArray Quality Control (MAQC) Project Meeting on MicroArray Quality Control.'' The focus of the 2-day meeting was to review the datasets generated by the MAQC study.  View details. [PDF] [WORD]
  • September 22, 2005 (Teleconference), Summary [Word]  [PDF]
  • September 8, 2005 (Teleconference), Summary [Word]  [PDF]
  • August 25, 2005 (Teleconference), Summary [Word]  [PDF]
  • August 11, 2005 (Teleconference), Summary [Word]  [PDF]
  • July 28, 2005 (Teleconference), Summary [Word]  [PDF]
  • July 14, 2005 (Teleconference), Summary [Word]  [PDF]
  • June 30, 2005 (Teleconference), Summary [Word]  [PDF]
  • June 16, 2005 (Teleconference), Summary [Word]  [PDF]
  • June 2, 2005 (Teleconference), Summary  [Word]  [PDF]
  • May 19, 2005 (Teleconference), Summary [Word]  [PDF]
  • May 2-3, 2005 (Face-to-face meeting at FDA/CDER, Rockville, Maryland).  Meeting Agenda [Word] [PDF], Summary  [Word]  [PDF]
  • April 22, 2005 (Teleconference on the analysis of the MAQC pilot study datasets. No summary is available.)
  • April 8, 2005 (Teleconference on the progress of the MAQC pilot study. No summary is available.)
  • March 25, 2005 (Teleconference), Summary [Word]  [PDF]
  • March 11, 2005 (Teleconference), Summary [Word]  [PDF]
  • February 25, 2005 (Teleconference), Summary [Word]  [PDF]
  • February 11, 2005 (Face-to-face meeting at FDA/NCTR, Jefferson, Arkansas). Agenda [Word] [PDF], Summary [Word]  [PDF]


Contact Information

Please address any questions and suggestions to Dr. Leming Shi at +1-870-543-7387 (voice) or leming.shi@fda.hhs.gov. 

Mailing address:  Leming Shi, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079, U.S.A.

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