The FDA Utilizes The Rosetta Syllego System To Support Management Of Genome-Wide Association Study Data Submitted Through The VXDS Program
Seattle, WA - Rosetta Biosoftware recently announced that the U.S. Food and Drug Administration (FDA) will utilize the Rosetta Syllego system to meet its immediate need for a software solution to manage and analyze genotyping data used in genome-wide association (GWA) studies. Organizations are now beginning to submit genotyping data from GWA studies to the FDA through its Voluntary eXploratory Data Submission (VXDS) program. Research organizations conducting GWA studies have the potential to reveal genetic risk factors for diseases such as coronary artery disease, type 2 diabetes and other complex diseases.
The use of genomic data is increasingly becoming an integral part of drug and diagnostic development. The VXDS program provides an opportunity for sponsors to submit genomic data for review by the FDA in a non-regulatory context. VXDS submissions provide a means to ensure that reviewers at the FDA are familiar with and prepared to appropriately evaluate future genomics submissions, and for sponsors to understand the FDA regulatory process. To streamline the evaluation of submissions and to develop a common understanding of genomic data, the FDA also extended the Micro Array Quality Control (MAQC) program to establish microarray quality control tools and guidelines for genotyping data used in GWA studies.
"There are a growing number of genome-wide association study data submissions to the FDA through VXDS," said Weida Tong, Ph.D., Director, Center for Toxicoinformatics, National Center for Toxicological Research (NCTR)/FDA. "A genotyping solution, such as the Syllego system, will benefit both the industry and the FDA because it allows us to effectively manage genotyping data submissions and also carry out analyses to understand why the sponsor might have used a particular method to arrive at a specific outcome. We will also explore the possibility of integrating the Syllego system with the ArrayTrack software developed by the FDA."
The Syllego system is a genetic data management and analysis system that includes tools for data management, quality control, data analysis, and meta-analysis. The system provides a single repository for fast, easy access to public and private data sets, reference annotation, and non-clinical and clinical information.
In addition to the Rosetta Syllego system, another Rosetta Biosoftware product, the Rosetta Resolver system for gene expression data management and analysis, is currently in place at the FDA's Center for Drug Evaluation and Research (CDER). The FDA uses the Resolver system and other gene expression tools alongside the FDA's genomic tool, ArrayTrack, to support the VXDS program. The Resolver system was also adopted by the Critical Path Institute, a non-profit research and education institution founded to help implement the FDA's Critical Path Initiative.
"We are proud to extend our relationship with the FDA, and to provide the FDA with powerful capabilities to manage and analyze genetic data," said Yelena Shevelenko, vice president and general manager of Rosetta Biosoftware. "By providing the Syllego system to the FDA for use with its VXDS initiative, the FDA can focus its attention on understanding the outcome of a GWA study. More importantly, by enabling the FDA with the technological capabilities of the Syllego system, we will move the whole research community forward to achieve the goals of personalized [translational] medicine."
Rosetta Biosoftware will present a Webinar featuring Federico Goodsaid, Ph.D., and CDER/FDA on October 10, 2007. This Webinar will discuss the FDA-initiated MAQC project focusing on genome-wide association studies. For more information or to register for this Webinar, please visit www.rosettabio.com/Webinars.
SOURCE: Rosetta Biosoftware