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Silicon Genetics Delivers Gene Expression Analysis Solution That Enables Compliance With FDA 21 CFR Part 11 Requirements


10/19/2005 5:09:16 PM

Compliance With FDA's Rule on Electronic Signatures, MAGE-ML Export, Among Key Features in New Release of GeNet(TM) and GeneSpring(R) Software

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Nov. 24, 2003-- Silicon Genetics today announced the immediate availability of GeNet(TM) 4.1 and GeneSpring® 6.1, the latest versions of the most widely used suite of software for analyzing gene expression information. Among the wealth of new features introduced are facilities to expedite compliance with the U.S. Food and Drug Administration's Title 21 Code of Federal Regulations Part 11. The FDA 21 CFR Part 11 regulations provide guidelines for companies using computerized systems to create and maintain records submitted to the FDA as part of a regulatory filing.

"As a technology critical to many facets of life science research, gene expression analysis is increasingly utilized in areas relevant to the drug discovery process," said Kevin Wandryk, Vice President of Marketing and Business Development for Silicon Genetics. "Whether in disease research, toxicogenomics, or clinical applications, the potential benefits are profound. As such, pharmaceutical organizations are beginning to demand expression analysis solutions that enable FDA approved workflows. We've designed GeNet 4.1 in close collaboration with leading pharmaceutical customers to ensure it meets and exceeds their regulatory requirements."

Silicon Genetics' GeNet software is a highly scalable analysis platform for managing and mining expression data in a workgroup or an enterprise setting, and is deployed in over 40 leading pharmaceutical, biotechnology, academic and government research organizations worldwide. GeNet 4.1 now empowers pharmaceutical and biotechnology companies to comply with FDA 21 CFR Part 11 requirements through the addition of a variety of new features, including:

Audit trails to record the creation, modification and deletion of relevant records Security enhancements to authenticate users and administrators Electronic signatures applied to the creation and modification of data objects Implementation Guidelines for archiving records and implementing Standard Operating Procedures (SOP's) For more information on GeNet 4.1, please visit: http://www.silicongenetics.com/gn.html.

The company also announced the immediate availability of GeneSpring 6.1, its powerful desktop tool for visualization and analysis of genomic expression data. Some of the extensive new features introduced in GeneSpring 6.1 include:

MAGE-ML support. Users can now export expression data in MAGE-ML (Microarray Gene Expression -- Markup Language) format to facilitate the exchange of data with other applications and databases Principal Component Analysis (PCA) on Conditions; a powerful visualization tool for quality control and sample classification Extended search, query and synchronization facilities that allow GeneSpring users to more effectively centralize and manage data using GeNet Broader access to pathway data, including over 100 curated pathways from GenMAPP.org and extended tools to import inter-species and organism specific pathways from the Kyoto Encyclopedia of Genes and Genomes (KEGG) For more information on GeneSpring 6.1, or to download a fully functional trial version, go to: http://www.silicongenetics.com/gs.html.

About Silicon Genetics

Silicon Genetics is the leading provider of expression data analysis and management solutions that accelerate the pace of functional genomics research and drug discovery. With combined expertise in biostatistics, molecular biology, and information technology, Silicon Genetics is the only company to offer scalability that meets the demands of both high throughput sample volumes and increasing numbers of users. Thousands of scientists at hundreds of organizations, including 11 of the world's top 13 pharmaceutical companies, currently use Silicon Genetics desktop and enterprise solutions to advance their research. Additional information about Silicon Genetics and its products and services can be found at www.silicongenetics.com.

Contact:

Silicon Genetics Kevin Wandryk, 650-367-9600 information@silicongenetics.com

Source: Silicon Genetics


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