FDA Licenses the Rosetta Resolver® System
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Rosetta Biosoftware has announced 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 is designed to provide 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.
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.
He adds, "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."
