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Executive Summary
[Word]
[PDF]
Purpose
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.
Timeline/Milestones
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
- February 11, 2005 (Face-to-face meeting at FDA/NCTR, Jefferson,
Arkansas). Agenda [Word]
[PDF], Summary [Word]
[PDF]
- February 25, 2005 (Teleconference), Summary [Word]
[PDF]
- March 11, 2005 (Teleconference), Summary [Word]
[PDF]
- March 25, 2005 (Teleconference), Summary [Word]
[PDF]
- April 8, 2005 (Teleconference on the progress of the MAQC pilot
study. No summary is available.)
- April 22, 2005 (Teleconference on the analysis of the MAQC pilot
study datasets. No summary is available.)
- May 2-3, 2005 (Face-to-face meeting at FDA/CDER, Rockville,
Maryland). Meeting Agenda [Word]
[PDF],
Summary [Word]
[PDF]
- May 19, 2005 (Teleconference), Summary [Word]
[PDF]
- June 2, 2005 (Teleconference), Summary [Word]
[PDF]
- June 16, 2005 (Teleconference), Summary [Word]
[PDF]
- June 30, 2005 (Teleconference), Summary [Word]
[PDF]
- July 14, 2005 (Teleconference), Summary [Word]
[PDF]
- July 28, 2005 (Teleconference), Summary [Word]
[PDF]
- August 11, 2005 (Teleconference), Summary [Word]
[PDF]
- August 25, 2005 (Teleconference), Summary [Word]
[PDF]
- September 8, 2005 (Teleconference), Summary [Word]
[PDF]
- September 22, 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]
- October 6, 2005 (Teleconference), Summary [Word]
[PDF]
- October 20, 2005 (Teleconference), Summary [Word]
[PDF]
- November 3, 2005 (Teleconference), Summary [Word]
[PDF]
- November 17, 2005 (Teleconference), Summary [Word]
[PDF]
- December 1-2, 2005 (face-to-face meeting at Palo Alta, Ca).
Meeting Agenda [Word]
[PDF],
Summary [Word]
[PDF]
- December 15, 2005 (Teleconference), Summary [Word]
[PDF]
- January 12, 2006 (Teleconference), Summary [Word]
[PDF]
- January 26, 2006 (Teleconference), Summary [Word]
[PDF]
- February 3-4, 2006 (face-to-face meting at Boston, MA). Meeting
Agenda [Word]
[PDF],
Summary [Word]
[PDF]
- February 9, 2006 (Teleconference), Summary [Word]
[PDF]
- February 23, 2006 (Teleconference), Summary [Word]
[PDF]
- March 9, 2006 (Teleconference), Summary [Word]
[PDF]
- March 20, 2006 (face-to-face meeting at San Diego, CA) [Word] [PPT]
[PDF]
- March 23, 2006 (Teleconference), Summary [Word]
[PDF]
- April 6, 2006 (Teleconference), Summary [Word]
[PDF]
- April 20, 2006 (Teleconference), Summary [Word]
[PDF]
- May 4, 2006 (Teleconference), Summary [Word]
[PDF]
- Federal Register notice - MAQC Follow-up on predictive signatures [PDF]
- May 18, 2006 (Teleconference), Summary [Word]
[PDF]
- September 8, 2006, MAQC Phase I results were published in
Nature
Biotechnology.
- September 8, 2006, The MicroArray Quality Control (MAQC) Project
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]
- 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]
- 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]
- March 24-26, 2008, The 8th MAQC project
face-to-face meeting was held at Rockville, MD. Final Agenda
[PDF],
Summary [PDF]
Links
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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