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| FDA Chief Health Informatics Officer Dr. Taha Kass-Hout--Courtesy of the FDA |
The FDA has started testing the precisionFDA platform it developed with DNAnexus. The closed beta test phase is the precursor to a more widespread rollout of the system, which the CEO of DNAnexus has described as being "the most advanced bioinformatics platform in the world."
DNAnexus was enlisted by the FDA to help with the project in August. The collaborators are trying to create an open-source platform to which developers of NGS-based diagnostics can upload data. Users can silo their data or make them available to the wider community. Giving the industry a place to share and analyze reference genomes, bioinformatics pipelines and genomic data is part of the FDA's strategy to establish processes and standards that drive improvements to the accuracy and reliability of NGS-based tests.
"It's a sandbox. It's a place where community can come and work toward advancement of regulatory science for this really important work," Taha Kass-Hout, chief health informatics officer at the FDA and architect of openFDA, said at an event attended by fedscoop. "Our particular interest is databases as a source of clinical validation evidence for particular variants, groups of variants, haplotypes, … so different test developers are not required to generate the data themselves," an unidentified FDA speaker said at the event, according to Regulatory Focus.
With the diagnostics sector making NGS a focus and President Barack Obama's Precision Medicine Initiative tasking the FDA with establishing a system for evaluating such products, the regulator is moving quickly. The advance of the precisionFDA platform into closed beta testing comes just three months after the FDA handed DNAnexus a $850,000 contract to work on the project. The FDA is planning to open up the testing phase in the coming weeks, with a view to enabling users to run certain analyses on their data by December 15.
The speed with which the platform is being developed is one of several ways in which it differs from traditional federal IT projects. DNAnexus and the FDA are applying agile design practices and will make the code available on GitHub.
- read fedscoop's article
- here's Regulatory Focus' take
- and the FDA's briefing document (PDF)