The U.S. Food & Drug Administration has unveiled its open-source genomic platform, PrecisionFDA, in a "closed beta," according to Fedscoop.
In introducing the concept, part of the Precision Medicine Initiative, in August, FDA officials said the platform will "supply an environment where the community can test, pilot, and validate new approaches" to next-generation sequencing tests.
Taha Kass-Hout, M.D., FDA's chief health informatics officer, describes the platform as a sandbox, according to Fedscoop. "It's a place where community can come and work toward advancement of regulatory science for this really important work," he said.
Built using agile development processes, the open source software will be available on GitHub, Kass-Hout said. It's comprised of the same concepts at OpenFDA, which uses application programming interfaces to make FDA data sets publicly available to third-party application developers.
PrecisionFDA eventually will allow researchers to upload and share three types of data:
- Reference genomes, which researchers can compare against other genome samples to help uncover genetic indicators that may predispose someone to a disease.
- Bioinformatics pipelines that make sense of the sequenced data.
- Genomic data, with which users will be able to run data in different pipelines and compare results.
You can find the portal at precision.fda.gov, but must request access to upload data. Users will be able to run some analysis of their data after Dec. 15.
The Precision Medicine Initiative, which the president introduced in his State of the Union address, involves multiple government agencies in furthering genomic research to tailor treatment to individual patients.
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