cGMP Compliance Development Is Also Approaching Completion
RESEARCH TRIANGLE PARK, N.C., Sept. 20 /PRNewswire-FirstCall/ -- Icoria,
Inc. (Nasdaq: ICOR), a biotechnology company, announced today that its service
unit, Paradigm Array Labs (PAL) has developed a gene expression profiling
quality system compliant with applicable Good Laboratory Practice (GLP)
requirements as the cornerstone to implementing current Good Manufacturing
Practice (cGMP) compliance in the coming months. These initiatives will enable
PAL to immediately expand its services into preclinical settings where
adherence to regulatory guidelines is mandatory. Following recent FDA draft
guidance on pharmacogenomics data, Icoria's ultimate goal is to establish a
cGMP compliant laboratory to also process its clients' clinical submissions
data.
"We are pleased to be able to provide gene expression profiling services
within a GLP-compliant environment. This is an important manifestation of the
continued growth and quality of our programs, and we believe this service
expansion will lead to additional revenue opportunities for PAL. We are
delighted to receive and interact with clients for gene expression profiling
services and welcome their necessary audits," said Heiri Gugger, PhD,
President and CEO of Icoria, Inc.
"With a stringent Chain-of-Custody program in place, clients of PAL will
be assured the strictest confidence and highest level of quality assurance in
the processing of their samples. We are now in the position to meet the
relevant requirements outlined in 21 CFR Part 58. PAL's well-documented and
proven laboratory flow process has recently completed a successful audit by a
prospective client," said Patrick Hurban, PhD, Director of Investigational
Genomics.
Paradigm Array Labs, with its broad portfolio of service offerings, is the
only authorized/certified service provider for both the Affymetrix and Agilent
gene expression analysis platforms. Additionally, PAL is the only Arcturus
Microgenomics Service Provider.
About Icoria
Formerly known as Paradigm Genetics, Icoria is a biotechnology company
applying its proprietary systems biology platform to the discovery and
development of safer, more effective drugs and agrichemicals. Icoria has major
collaborations with the National Institute of Environmental Health Sciences,
Bayer CropScience, the Monsanto Company, Pioneer Hi-Bred International (a
subsidiary of DuPont), the National Institute of Standards & Technology's
Advanced Technology Program, and L'Oreal Inc. For more information,
visit http://www.icoria.com .
This press release contains forward-looking statements, including
statements regarding the Company's expectations for using its systems biology
platform to discover biomarkers and inaccessible targets for small molecule
discovery. Such forward-looking statements are based on management's current
expectations and are subject to a number of risks, factors and uncertainties
that may cause actual results, events and performance to differ materially
from those referred to in the forward-looking statements. These risks, factors
and uncertainties include, but are not limited to, Icoria's early stage of
development, history of net losses, technological and product development
uncertainties, reliance on research collaborations, uncertainty of additional
funding and ability to protect its patents and proprietary rights. Certain of
these and other risks are identified in Icoria's annual report on Form 10-K
for the year ended December 31, 2003 and in its quarterly report on Form 10-Q
for the quarter ended June 30, 2004, each filed with the Securities and
Exchange Commission. The Company does not intend to update any of the forward-
looking statements after the date of this release to conform these statements
to actual results or to changes in our expectations, except as may be required
by law.
SOURCE Icoria, Inc.
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Related links:
http://www.icoria.com
CONTACT:
Brian Ritchie or Mark Vincent of EURO RSCG
Life NRP, +1-212-845-4200
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