News

Posted On: 08/24/2005

FDA Licenses Rosetta Resolver System for Use in the CDER

PharmaManufacturing.com

Seattle-based Rosetta Biosoftware announced August 24 that the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) will evaluate the Rosetta Resolver system for gene expression data management and analysis. CDER will use the Rosetta Resolver system in the Voluntary Genomics Data Submissions (VGDS) program to analyze microarray data from sponsors. The VGDS program provides a means for sponsors to ensure that regulatory scientists are familiar with and are prepared to appropriately evaluate future genomics submissions.

CDER will use the Rosetta Resolver system to better understand, learn from and reproduce analyses conducted by pharmaceutical companies who voluntarily submit genomics data. In addition, they will perform independent analyses using the Rosetta Resolver system's microarray data management and analysis tools.

"As the VGDS program gains momentum, CDER will receive a wide variety and growing volume of gene expression data," said Yelena Shevelenko, vice president and general manager of Rosetta Biosoftware. "The Rosetta Resolver system's robust capacity, ability to analyze and manage varying data formats, and support of industry standards allows it to efficiently accept and manage these data. In addition, Rosetta Biosoftware is committed to work with sponsors and the FDA to simplify and standardize the submission process."

The Rosetta Resolver system is developed and supported by Rosetta Biosoftware, and is distributed exclusively by Agilent Technologies, Inc.

About the Rosetta Resolver System

The Rosetta Resolver system is a high-capacity data storage, retrieval and analysis solution for gene expression data. The system is ideal for life science research organizations that need to assess compound specificity or toxicity, identify new genes or therapeutic targets or compare and analyze large databases of expression profiles.

The Rosetta Resolver system combines flexibility and ease of use with high-performance algorithms to produce a comprehensive solution for rapid analysis of gene expression data. The system can accept and analyze data from a wide variety of expression profiling formats, including Agilent DNA microarrays, and applies Rosetta Biosoftware's proprietary error models to yield quality statistics for every gene expression measurement within the system. These statistics are automatically leveraged by Rosetta Resolver system analysis tools for optimal results. Additional information about the Rosetta Resolver system can be found on the Rosetta Biosoftware Web site at www.rosettabio.com.