The FDA has outlined how it will spend the $10 million it is set to receive as part of President Obama's Precision Medicine Initiative. The road map includes full or hybrid cloud storage, open-source data sharing platforms and Google-esque search tools.
Regulatory officials went over their plans at a briefing attended by GenomeWeb. The end goal is to equip the FDA to manage the flood of data that will come its way as more and more applications for NGS tests start to roll in. The FDA established a model for handling NGS diagnostics when Illumina ($ILMN) applied for approval of MiSeqDx-based cystic fibrosis tests--which were cleared after being analyzed alongside a Johns Hopkins database--and plans to use some of the cash to expand this approach.
"We want to put some money toward advancing the development of high-quality, curated databases that are similar to the cystic fibrosis database that we used for the Illumina test," Elizabeth Mansfield, deputy office director for personalized medicine at FDA, said. The National Institutes of Health's Clinical Genome Resource is expected to play a role, but FDA is still on the lookout for more resources. Such databases will free developers from the need to run new studies to clinically validate NGS tests.
The enterprise throws up new challenges for FDA, which has a patchy track record with IT initiatives. However, openFDA sits squarely in the 'success' column and its architect--Chief Health Informatics Officer Taha Kass-Hout--is set to play a role in the precision medicine program. Kass-Hout is keen to use open-source platforms to enable data sharing--regardless of whether they come from a proprietary source--and give users Google-esque search tools to zero in on clinical validity information.
- read GenomeWeb's article (reg. req.)