FDA unveils precision medicine platform

"PrecisionFDA will supply an environment where the community can test, pilot, and validate new approaches."
By Tom Sullivan
03:27 PM
DNA

The U.S. Food and Drug Administration on Wednesday revealed that it is working to build a software platform for precision medicine and an informatics community around it.

FDA's Office of Health Informatics, in fact, contracted with DNAnexus, to create open source cloud-based software for sharing genomic information.

Dubbed precisionFDA, the platform can be used to evaluate bioinformatics workflows and essentially crowdsource reference data sets, according to DNAnexus, which describes itself as a cloud-based genome informatics and data management company.

President Obama's Precision Medicine Initiative will necessitate that fashion of collaboration, Taha Kass-Hout, MD, FDA's chief health informatics officer and FDA policy advisor David Litwack wrote in a blog post.

"To begin to realize this new vision, precisionFDA is designed to develop the necessary standards. PrecisionFDA will supply an environment where the community can test, pilot, and validate new approaches," Kass-Hout and Litwack wrote, providing as example of the opportunity for developers, research, and others to not only share but also cross-validate test results against reference materials.

When the precisionFDA beta opens, slated for December of 2015, users will be able to access independent work areas for software code or data that can either be kept private or shared with whomever the contributor chooses. 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 noted.