FDA Clears First NGS System for Clinical Use

The FDA granted premarket clearance for the Illumina MiSeqDx high-throughput, next generation gene sequencing instrument.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htm

This is the first benchmark sequencer designed and validated for the clinical market.  The instrument is also CE marked for use internationally.

They were able to successfully “benchmark” the performance of the system against a publicly available quality scored genome that was created in collaboration with the National Institute of Standards and Technology (NIST).

Two matching Cystic Fibrosis diagnostic kits available have also been approved.

The FDA also granted approval for the Illumina Universal Kit reagents, allowing laboratories to more easily develop and validate other sequencing assays using the platform.