FDA Approves First Next-Generation DNA Sequencing Platforms

High-throughput, next-generation DNA sequencing (NGS) devices received their first regulatory clearances from FDA Nov. 19 when the agency granted de novo approvals to two nondisease-specific diagnostic platforms made by Illumina Inc.

Illumina’s MiSeqDxPlatform instrumentation and MiSeqDx Universal Kit 1.0 allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA said in announcing the precedent-setting decision