Rosetta Biosoftware has 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.
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.
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.