FDA approves first next-gen sequencer

FDA approved the MiSeqDx genome sequencing system from Illumina Inc. (NASDAQ:ILMN) -- the first high-throughput, next-generation genomic sequencer to be approved by the agency. The whole genome benchtop sequencer, which has been available for research-use only, is now approved in the U.S. for broad clinical use. In an cytochrome P450 family 2 subfamily C polypeptide 9 (CYP2C9) and vitamin K epoxide reductase complex subunit 1 (VKORC1) did not improve the effectiveness of the anticoagulants.

Senior FDA officials recently endorsed the use of next-generation sequencing as an alternative to companion diagnostics (see BioCentury, Nov. 4). ...