Affymetrix Participates in Study to Advance MicroArray Technology Towards Widespread Clinical Use; GeneChip(R) Technology Demons
September 08 2006 - 3:04PM
Business Wire
Affymetrix Inc. (Nasdaq:AFFX) announced today 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(R) arrays demonstrated the best reproducibility
within and across sites, an element critical for the success of
clinical studies. Affymetrix GeneChip arrays also showed the best
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: -
Reproducibility - 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(1). - Robustness - Affymetrix was shown to have the
most robust platform--it was the only manufacturer that did not
remove or repeat data from any sites(2). - Sensitivity - Affymetrix
technology demonstrated the best apparent power, or sensitivity, in
detecting changes in gene expression(3). - Controls - Affymetrix is
the only participating platform that provides a comprehensive panel
of controls, which is critical for the evaluation of clinical
samples(4). 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. Beginning Monday, 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. For more information and to register
when available, please visit:
http://www.affymetrix.com/userforum/index.uf. About Affymetrix
Affymetrix scientists invented the world's first high-density
microarray in 1989 and began selling the first commercial
microarray in 1994. Since then, Affymetrix GeneChip(R) technology
has become the industry standard in molecular biology research.
Affymetrix technology is used by the world's top pharmaceutical,
diagnostic and biotechnology companies as well as leading academic,
government and not-for-profit research institutes. More than 1,400
systems have been installed around the world and more than 7,000
peer-reviewed papers have been published using the technology.
Affymetrix' patented photolithographic manufacturing process
provides the most information capacity available today on an array,
enabling researchers to use a whole-genome approach to analyzing
the relationship between genetics and health. Affymetrix is
headquartered in Santa Clara, Calif., with manufacturing facilities
in Sacramento, Calif., and Bedford, Mass. The company maintains
important sales and marketing operations in Europe and Asia and has
about 1,100 employees worldwide. For more information about
Affymetrix, please visit the company's website at
www.affymetrix.com. All statements in this press release that are
not historical are "forward-looking statements" within the meaning
of Section 21E of the Securities Exchange Act as amended, including
statements regarding Affymetrix' "expectations," "beliefs,"
"hopes," "intentions," "strategies," or the like. Such statements
are subject to risks and uncertainties that could cause actual
results to differ materially for Affymetrix from those projected,
including, but not limited to: risks of the Company's ability to
achieve and sustain higher levels of revenue, higher gross margins,
reduced operating expenses; uncertainties relating to technological
approaches, manufacturing, product development; personnel
retention; uncertainties related to cost and pricing of Affymetrix
products; dependence on collaborative partners; uncertainties
relating to sole source suppliers; uncertainties relating to FDA
and other regulatory approvals; competition; risks relating to
intellectual property of others and the uncertainties of patent
protection and litigation. These and other risk factors are
discussed in Affymetrix' Form 10-K/A for the year ended December
31, 2005, and other SEC reports, including its Quarterly Reports on
Form 10-Q for subsequent quarterly periods. Affymetrix expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein to reflect any change in Affymetrix' expectations with
regard thereto or any change in events, conditions or circumstances
on which any such statements are based. NOTE: Affymetrix, the
Affymetrix logo, and GeneChip are registered trademarks owned or
used by Affymetrix Inc. (1) The MicroArray Quality Control (MAQC)
Project shows interplatform reproducibility of gene expression
measurements; Figure 1 and Figure 2. (2) The MicroArray Quality
Control (MAQC) Project shows interplatform reproducibility of gene
expression measurements; Table 1. Supplementary Information on MAQC
Study; Table S3. (3) Supplementary Information on MAQC Study;
Section H. (4) Evaluation of external RNA controls for the
assessment of microarray performance.
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