cGMP compliance development is also approaching completion

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 Following recent FDA draft guidance on pharmacogenomics data, Icoria's ultimate goal is to establish a cGMP compliant laboratory to also process its clients’ clinical submissions data.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.

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'Oréal Inc.