The NIH Director
Statement on FDA Clearance of Genomic Sequencing Device for Clinical Use
In a landmark move that will help to realize the promise of personalized medicine, the U.S. Food and Drug Administration (FDA) today announced the first regulatory clearance of a high-throughput DNA sequencing device. This action reflects our nation’s commitment to a future in which health-care professionals will be able to use each person’s unique genetic information to provide more precise ways of detecting, treating, and preventing disease.
Specifically, the FDA authorized broad clinical use of Illumina MiSeq Dx, a sophisticated DNA sequencing system that traces its roots back to NIH-funded science and that, until now, has only been used for research. I commend the FDA not only for the immediate impact of its decision, but for the pathway it has created for the clearance of future devices that may incorporate further improvements in sequencing technology and cost effectiveness.
The availability of high-throughput DNA sequencers will enable physicians to take a comprehensive look at a patient’s genetic blueprint, or genome, to search for a wide range of variations or changes that increase risk of disease, drive the disease process, and/or affect response to medications and other treatments. Such information has the potential to benefit patients in many ways. For example, an oncologist might use results of a sequencing scan to choose the chemotherapy drug that is most likely to work.
As exciting as it may be, today’s action really is just the beginning. We still need to establish the clinical validity of new genomic findings before they are used to make medical decisions. We also need to work hard to ensure that physicians and other health-care professionals have the tools they need to use genomic information well. So, while we may have taken one important stride today down the path towards personalized medicine, we must take many more if we are to achieve its full potential for improving human health.
Francis S. Collins, M.D., Ph.D.
Director, National Institutes of Health
FDA News: FDA allows marketing of four “next generation” gene sequencing devices, November 19, 2013
Francis S. Collins, M.D., Ph.D., and Margaret A. Hamburg, M.D., First FDA Authorization for Next-Generation Sequencer. November 19, 2013 DOI: 10.1056/NEJMp1314561.