FDA contracts for Precision Medicine platform
The Food and Drug Administration's Office of Health Informatics has contracted with DNAnexus to create open source cloud-based software for sharing genomic information as part of the Obama administration's precision medicine initiative.
DNAnexus has been awarded a research and development contract to build precisionFDA, an open source platform for community sharing of genomic information.
The platform allows a streamlined approach to evaluating next-generation sequencing-based diagnostics and its creation of reference datasets will build a community around best practices resources and democratize the submission process to the FDA, according to a release.
The FDA has adopted a community approach to crowd source reference analytical pipelines and datasets for the testing validation process by the community members who will be utilizing them. DNAnexus will work with the FDA to build a community around its informatics platform to help drive standards around secondary analysis, the process of mapping, alignment and variant calling of DNA sequence data.
President Obama's Precision Medicine Initiative will necessitate that fashion of collaboration.
"PrecisionFDA will supply an environment where the community can test, pilot, and validate new approaches," wrote Taha Kass-Hout, MD, FDA's chief health informatics officer and FDA policy advisor David Litwack, PhD, in a blog post on FDAVoice. They said developers, researchers and others will be able to not only share but also cross-validate test results against reference materials.
When the precisionFDA beta opens—scheduled for December—users will be able to access independent work areas for software code or data that can either be kept private or shared. The public space will host tools including a wiki, open access reference genomic data models and analytics.
"We believe precisionFDA will help us advance the science around the accuracy and reproducibility of next generation sequencing-based tests, and in doing so, will advance consumer safety," Kass-Hout and Litwack wrote.
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Editor Beth earned a bachelor’s degree in journalism and master’s in health communication. She has worked in hospital, academic and publishing settings over the past 20 years. Beth joined TriMed in 2005, as editor of CMIO and Clinical Innovation + Technology. When not covering all things related to health IT, she spends time with her husband and three children.