The FDA has picked DNAnexus to get its IT preparations for the Precision Medicine Initiative underway. The deal gives DNAnexus a starring role in the creation of precisionFDA, an open-source platform the FDA sees as a way to manage the anticipated surge in the amount of genomic data the industry has to handle.
President Barack Obama's Precision Medicine Initiative has tasked the FDA with setting up a system to handle diagnostics based on next generation sequencing (NGS) technologies, an emerging class of products that will stretch IT capabilities at the regulator and the companies it serves. Faced with the task, the FDA has handed DNAnexus a contract worth nearly $850,000 to build precisionFDA. The goal of the program is to set up a centralized repository through which developers of NGS-based diagnostics can share data with the FDA and collaborators, giving the industry a way to assess the accuracy of tests.
Taha Kass-Hout, chief health informatics officer at the FDA and architect of openFDA, is behind the plan. The next steps are to set up the system with DNAnexus, start to build the community that will be essential to its success and assess exactly how the platform fits into workflows at the FDA. "We're not saying precisionFDA is going to be the regulatory system necessarily. But it's definitely going to be a tool that will help streamline innovation and the process of validating [tests]," Kass-Hout told Xconomy.
Kass-Hout is aiming to have a beta version of the platform ready before the end of the year, a timeline he described as "very, very tight." The tasks facing the collaborators include the establishment of auditable levels of security, privacy and governance control, the provision of reference genomic models and the creation of a wiki.