Collins on the FDA Approval of Illumina's MiSeqDx

November 20, 2013

November 20, 2013 | Yesterday the FDA granted premarket clearance to Illumina's MiSeqDx platform as well as several diagnostic kits to go with the platform. Francis Collins, in a Perspective comment at the New England Journal of Medicine, said that the FDA's authorization will open the door "for the development and use of innumerable new genome-based tests." In his statement on the NIH website, Collins called the approval, "a landmark move that will help to realize the promise of personalized medicine", but also a first step, stressing that there is still work needed to establish the clinical validity of new genomic findings before they are incorporated into medical decision-making.