Next-gen DNA sequencing system receives FDA approval for clinical use

Nov. 20, 2013

The FDA has authorized broad clinical use of the MiSeq Dx DNA sequencing system from Illumina, which until now has only been used for research.

The FDA has authorized broad clinical use of the MiSeq Dx DNA sequencing system from Illumina (San Diego, CA), which until now has only been used for research. FDA approval for the system will help to realize the promise of personalized medicine, enabling use of a patient's unique genetic information to provide more precise ways of detecting, treating, and preventing disease.

Related: A high-performance, low-cost approach to next-generation sequencing

The availability of next-generation 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.

The benchtop system, with a portfolio of FDA-cleared in vitro diagnostic kits and assays, leverages the companyâs sequencing by synthesis (SBS) chemistry. The MiSeqDx Cystic Fibrosis 139-Variant Assay is designed for simultaneous detection of 139 clinically relevant disease-causing mutations and variants within the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The assay includes all cystic fibrosis-causing variants recommended for carrier screening purposes by the American College of Medical Genetics and Genomics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG). The MiSeqDx Universal Kit enables clinical laboratories to develop their own diagnostic tests, and includes library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays on the in vitro diagnostic platform.

The system and assays are available for immediate order with shipment before the end of 2013 in the U.S. and Europe. For more information, please visit www.illumina.com/FirstNGSIVD.

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