|FDA Chief Health Informatics Officer Dr. Taha Kass-Hout--Courtesy of the FDA|
FDA has hit the tight timeline it set itself for the start of the precisionFDA open beta program. The system went live this week, just as the regulator forecast when it started a closed beta program last month.
Taha Kass-Hout, chief health informatics officer at FDA, committed to trying to have precisionFDA ready for testing by the end of the year back when the regulator first outlined the project in August. That Kass-Hout was willing to aim for such a timeline--which at the time he described as being "very, very tight"--and then went on to achieve it is testament to the new approach the regulator is taking to IT projects. Kass-Hout, as the architect of openFDA, has played a major role in ushering in the new era of IT at FDA, which in the past had a reputation for bungling the implementation of systems.
The upshot of hitting the timeline, which was achieved in collaboration with DNAnexus, is that FDA now has the makings of a platform to support the refinement of regulation of genome testing and software. Notably, the intention is to involve the industry in this process, using precisionFDA as the focal point for the collaborative evolution of standards. Specific functions of the platform include the ability to compare two sets of variants, a feature that has been welcomed by some observers.
"The idea of having good reference materials against which to measure the analytic validity of various tools, whether physical or computational, makes enormous sense," Hank Greely, director of the Center for Law and the Biosciences at Stanford University, told Fast Company. "Without a good reference, you don't know what you've got--a foot or an inch, an accurate sequencer or a poor one."