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FDA to Use Strand Life Sciences' Genomics Reviewer Desktop Software for VXDS Program


Originally published May 3.

Strand Life Sciences said this week that it has licensed to the US Food and Drug Administration its Genomics Reviewer Desktop software, which will enable the agency's reviewers to analyze pharmacogenomic data submitted through its Voluntary Exploratory Data Submissions program.

"GRD will enable FDA to integrate analyses needed to reconstruct a sponsor's interpretation of exploratory biomarker data by using multiple genomics tools and methods," Strand said in a statement. "This effort contributes to the development of recommendations for the submission of genomic data."

Strand's GRD software will be integrated with ArrayTrack, a microarray analysis platform developed by scientists at FDA's National Center for Toxicological Research, as well as with other third-party analysis tools. As part of its agreement with Strand, the FDA has also licensed Avadis, Strand's data analysis and visualization platform, upon which GRD will run.

"GRD will help FDA reviewers to develop integrated data interpretation that is based on using multiple analysis tools and databases, as well as capture the underlying analysis process," Federico Goodsaid, associate director for operations in genomics at the Office of Clinical Pharmacology at FDA's Center for Drug Evaluation and Research, said in a statement. "A solution such as GRD will be advantageous to both the FDA and the industry to manage pharmacogenomic data submissions."

The FDA launched the VXDS program several years ago to encourage sponsors to share genomics data with the agency without any regulatory repercussions (PGx Reporter 11/29/06). According to agency officials, since 2008, submissions to the VXDS program have grown 250 percent.

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